Document and Entity Information
Document and Entity Information - USD ($) | 12 Months Ended | ||
Dec. 31, 2018 | Feb. 22, 2019 | Jun. 30, 2018 | |
Document and Entity Information [Abstract] | |||
Entity Registrant Name | ALIMERA SCIENCES INC | ||
Entity Central Index Key | 1,267,602 | ||
Document Type | 10-K | ||
Document Period End Date | Dec. 31, 2018 | ||
Amendment Flag | false | ||
Document Fiscal Year Focus | 2,018 | ||
Document Fiscal Period Focus | FY | ||
Current Fiscal Year End Date | --12-31 | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Voluntary Filers | No | ||
Entity Current Reporting Status | Yes | ||
Entity Filer Category | Accelerated Filer | ||
Entity Emerging Growth Company | false | ||
Entity Small Business | true | ||
Entity Shell Company | false | ||
Entity Public Float | $ 60,577,309 | ||
Entity Common Stock, Shares Outstanding | 70,968,630 |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
CURRENT ASSETS: | ||
Cash and cash equivalents | $ 13,043 | $ 24,067 |
Restricted cash | 32 | 34 |
Accounts receivable, net | 17,259 | 11,435 |
Prepaid expenses and other current assets | 2,109 | 2,278 |
Inventory (Note 5) | 2,405 | 1,508 |
Total current assets | 34,848 | 39,322 |
Property and equipment, net | 1,355 | 1,410 |
Intangible asset, net | 16,723 | 18,664 |
Deferred tax asset | 1,182 | 528 |
TOTAL ASSETS | 54,108 | 59,924 |
CURRENT LIABILITIES: | ||
Accounts payable | 6,355 | 5,905 |
Accrued expenses (Note 8) | 3,643 | 3,582 |
Capital lease obligations | 236 | 184 |
Total current liabilities | 10,234 | 9,671 |
NON-CURRENT LIABILITIES: | ||
Note payable (Note 10) | 37,873 | 34,365 |
Capital lease obligations — less current portion | 305 | 203 |
Other non-current liabilities | 2,974 | 766 |
COMMITMENTS AND CONTINGENCIES (Note 11) | ||
STOCKHOLDERS’ EQUITY: | ||
Common stock, $.01 par value — 150,000,000 shares authorized, 70,078,878 shares issued and outstanding at December 31, 2018 and 69,146,381 shares issued and outstanding at December 31, 2017 | 701 | 691 |
Additional paid-in capital | 346,108 | 341,622 |
Common stock warrants | 3,707 | 3,707 |
Accumulated deficit | (377,127) | (399,075) |
Accumulated other comprehensive loss — foreign currency translation adjustments | (1,011) | (821) |
TOTAL STOCKHOLDERS’ EQUITY | 2,722 | 14,919 |
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY | 54,108 | 59,924 |
Series A convertible preferred stock | ||
STOCKHOLDERS’ EQUITY: | ||
Preferred stock | 19,227 | 19,227 |
Series B convertible preferred stock | ||
STOCKHOLDERS’ EQUITY: | ||
Preferred stock | 0 | 49,568 |
Series C Convertible Preferred Stock | ||
STOCKHOLDERS’ EQUITY: | ||
Preferred stock | $ 11,117 | $ 0 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Preferred stock, par value (in dollars per share) | $ 0.01 | $ 0.01 |
Preferred stock, shares authorized | 10,000,000 | 10,000,000 |
Common stock, par value (in dollars per share) | $ 0.01 | $ 0.01 |
Common stock, shares authorized (in shares) | 150,000,000 | 150,000,000 |
Common stock, shares issued (in shares) | 70,078,878 | 69,146,381 |
Common stock, shares outstanding (in shares) | 70,078,878 | 69,146,381 |
Series A convertible preferred stock | ||
Preferred stock, shares authorized | 1,300,000 | 1,300,000 |
Preferred stock, shares issued (in shares) | 600,000 | 600,000 |
Preferred stock, shares outstanding (in shares) | 600,000 | 600,000 |
Preferred stock, liquidation preference | $ 24,000 | $ 24,000 |
Series B convertible preferred stock | ||
Preferred stock, shares authorized | 8,417 | 8,417 |
Preferred stock, shares issued (in shares) | 8,416.251 | 8,416.251 |
Preferred stock, shares outstanding (in shares) | 8,416.251 | 8,416.251 |
Preferred stock, liquidation preference | $ 50,750 | $ 50,750 |
Series C Convertible Preferred Stock | ||
Preferred stock, shares authorized | 10,150 | 0 |
Preferred stock, shares issued (in shares) | 10,150 | 0 |
Preferred stock, shares outstanding (in shares) | 10,150 | 0 |
Preferred stock, liquidation preference | $ 10,150 | $ 0 |
Consolidated Statements of Oper
Consolidated Statements of Operations - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Income Statement [Abstract] | ||
NET REVENUE | $ 46,970 | $ 35,912 |
COST OF GOODS SOLD, EXCLUDING DEPRECIATION AND AMORTIZATION | (4,679) | (3,438) |
GROSS PROFIT | 42,291 | 32,474 |
RESEARCH, DEVELOPMENT AND MEDICAL AFFAIRS EXPENSES | 11,274 | 12,844 |
GENERAL AND ADMINISTRATIVE EXPENSES | 14,525 | 13,039 |
SALES AND MARKETING EXPENSES | 23,517 | 23,210 |
DEPRECIATION AND AMORTIZATION | 2,645 | 2,684 |
RECOVERABLE COLLABORATION COSTS | 0 | (2,851) |
OPERATING EXPENSES | 51,961 | 48,926 |
NET LOSS FROM OPERATIONS | (9,670) | (16,452) |
INTEREST EXPENSE AND OTHER | (4,775) | (5,579) |
UNREALIZED FOREIGN CURRENCY (LOSS) GAIN, NET | (65) | 5 |
LOSS ON EARLY EXTINGUISHMENT OF DEBT | (1,766) | 0 |
CHANGE IN FAIR VALUE OF DERIVATIVE WARRANT LIABILITY | 0 | 188 |
NET LOSS BEFORE TAXES | (16,276) | (21,838) |
PROVISION FOR TAXES | (106) | (163) |
NET LOSS | (16,382) | (22,001) |
GAIN ON EXTINGUISHMENT OF PREFERRED STOCK | 38,330 | 0 |
NET INCOME (LOSS) AVAILABLE TO STOCKHOLDERS | $ 21,948 | $ (22,001) |
NET INCOME (LOSS) PER SHARE— Basic (USD per share) | $ 0.25 | $ (0.33) |
WEIGHTED AVERAGE SHARES OUTSTANDING - BASIC (in shares) | 88,002,208 | 66,993,649 |
NET INCOME (LOSS) PER SHARE — Diluted (USD per share) | $ 0.25 | $ (0.33) |
WEIGHTED AVERAGE SHARES OUTSTANDING — Diluted (in shares) | 88,737,788 | 66,993,649 |
Consolidated Statements of Comp
Consolidated Statements of Comprehensive Loss - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Statement of Comprehensive Income [Abstract] | ||
Net loss | $ (16,382) | $ (22,001) |
OTHER COMPREHENSIVE (LOSS) INCOME | ||
Foreign currency translation adjustments | (190) | 451 |
TOTAL OTHER COMPREHENSIVE (LOSS) INCOME | (190) | 451 |
COMPREHENSIVE LOSS | $ (16,572) | $ (21,550) |
Consolidated Statements of Chan
Consolidated Statements of Changes in Stockholders' Equity - USD ($) $ in Thousands | Total | Common Stock | Preferred StockSeries A Convertible Preferred Stock | Preferred StockSeries B Convertible Preferred Stock | Preferred StockSeries C Convertible Preferred Stock | Additional Paid-In Capital | Common Stock Warrants | Accumulated Deficit | Accumulated Other Comprehensive Loss |
BALANCE (in shares) at Dec. 31, 2016 | 64,862,904 | 600,000 | 8,416 | 0 | |||||
BALANCE at Dec. 31, 2016 | $ 25,586 | $ 649 | $ 19,227 | $ 49,568 | $ 0 | $ 330,781 | $ 3,707 | $ (377,074) | $ (1,272) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||||
Issuance of stock, net of issuance costs (in shares) | 4,282,748 | ||||||||
Issuance of stock, net of issuance costs | $ 5,901 | $ 42 | 5,859 | ||||||
Exercise of stock options (in shares) | 729 | 729 | |||||||
Exercise of stock options | $ 1 | 1 | |||||||
Stock-based compensation | 4,981 | 4,981 | |||||||
Net loss | (22,001) | (22,001) | |||||||
Foreign currency translation adjustments | 451 | 451 | |||||||
BALANCE (in shares) at Dec. 31, 2017 | 69,146,381 | 600,000 | 8,416 | 0 | |||||
BALANCE at Dec. 31, 2017 | 14,919 | $ 691 | $ 19,227 | $ 49,568 | $ 0 | 341,622 | 3,707 | (399,075) | (821) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||||
Issuance of stock, net of issuance costs (in shares) | 930,934 | ||||||||
Issuance of stock, net of issuance costs | $ 83 | $ 10 | 73 | ||||||
Exercise of stock options (in shares) | 1,563 | 1,563 | |||||||
Exercise of stock options | $ 2 | 2 | |||||||
Preferred stock exchange, net of transaction costs (Note 12) (in shares) | 8,416 | 10,150 | |||||||
Preferred stock exchange, net of transaction costs (Note 12) | (121) | $ (49,568) | $ 11,117 | 38,330 | |||||
Stock-based compensation | 4,411 | 4,411 | |||||||
Net loss | (16,382) | (16,382) | |||||||
Foreign currency translation adjustments | (190) | (190) | |||||||
BALANCE (in shares) at Dec. 31, 2018 | 70,078,878 | 600,000 | 0 | 10,150 | |||||
BALANCE at Dec. 31, 2018 | $ 2,722 | $ 701 | $ 19,227 | $ 0 | $ 11,117 | $ 346,108 | $ 3,707 | $ (377,127) | $ (1,011) |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
CASH FLOWS FROM OPERATING ACTIVITIES: | ||
Net loss | $ (16,382,000) | $ (22,001,000) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 2,645,000 | 2,684,000 |
Unrealized foreign currency transaction loss | 65,000 | (5,000) |
Amortization of debt discount | 842,000 | 1,416,000 |
Deferred taxes (benefit) | (653,000) | (92,000) |
Loss on early extinguishment of debt | 1,766,000 | 0 |
Stock compensation expense | 4,411,000 | 4,981,000 |
Change in fair value of derivative warrant liability | 0 | (188,000) |
Changes in assets and liabilities: | ||
Accounts receivable | (5,995,000) | 2,610,000 |
Prepaid expenses and other current assets | 129,000 | (67,000) |
Inventory | (933,000) | (1,018,000) |
Accounts payable | 556,000 | 644,000 |
Accrued expenses and other current liabilities | 1,547,000 | (271,000) |
Other long-term liabilities | 449,000 | (1,567,000) |
Net cash used in operating activities | (11,553,000) | (12,874,000) |
CASH FLOWS FROM INVESTING ACTIVITIES: | ||
Purchases of property and equipment | (175,000) | (238,000) |
Net cash used in investing activities | (175,000) | (238,000) |
CASH FLOWS FROM FINANCING ACTIVITIES: | ||
Proceeds from exercise of stock options | 2,000 | 1,000 |
Proceeds from sale of common stock | 83,000 | 6,084,000 |
Payment of issuance cost of common stock | 0 | (183,000) |
Issuance of debt | 40,000,000 | 0 |
Payment of principal on notes payable | (35,000,000) | |
Payment of extinguishment of debt costs | (2,544,000) | 0 |
Payment of deferred financing costs | (1,142,000) | 0 |
Payment of preferred stock exchange costs | (122,000) | 0 |
Payments on capital lease obligations | (327,000) | (182,000) |
Net cash provided by financing activities | 950,000 | 5,720,000 |
EFFECT OF EXCHANGE RATES ON CASH AND CASH EQUIVALENTS AND RESTRICTED CASH | (248,000) | 483,000 |
NET DECREASE IN CASH AND CASH EQUIVALENTS AND RESTRICTED CASH | (11,026,000) | (6,909,000) |
CASH AND CASH EQUIVALENTS AND RESTRICTED CASH — Beginning of year | 24,101,000 | 31,010,000 |
CASH AND CASH EQUIVALENTS AND RESTRICTED CASH — End of year | 13,075,000 | 24,101,000 |
SUPPLEMENTAL DISCLOSURES: | ||
Cash paid for interest | 3,571,000 | 4,117,000 |
Cash paid for income taxes | 239,000 | 74,000 |
Supplemental schedule of noncash investing and financing activities: | ||
Property and equipment acquired under capital leases | $ 575,000 | $ 282,000 |
Nature of Operations
Nature of Operations | 12 Months Ended |
Dec. 31, 2018 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
NATURE OF OPERATIONS | NATURE OF OPERATIONS Alimera Sciences, Inc., together with its wholly-owned subsidiaries (the Company), is a pharmaceutical company that specializes in the commercialization, research and development of ophthalmic pharmaceuticals. The Company was formed on June 4, 2003 under the laws of the State of Delaware. The Company is presently focused on diseases affecting the back of the eye, or retina, because the Company’s management believes these diseases are not well treated with current therapies and represent a significant market opportunity. The Company’s only commercial product is ILUVIEN ® , which has received marketing authorization in the United States (U.S.), Austria, Belgium, Canada, the Czech Republic, Denmark, Finland, France, Germany, Ireland, Italy, Lebanon, Luxembourg, the Netherlands, Norway, Poland, Portugal, Spain, Sweden, the United Arab Emirates and the United Kingdom. In the U.S., Canada, Lebanon and the United Arab Emirates, ILUVIEN is indicated for the treatment of diabetic macular edema (DME) in patients who have been previously treated with a course of corticosteroids and did not have a clinically significant rise in intraocular pressure (IOP). In the European Economic Area (EEA) countries in which ILUVIEN has received marketing authorization, it is indicated for the treatment of vision impairment associated with DME considered insufficiently responsive to available therapies. As part of the approval process in Europe, the Company committed to conduct a five -year, post-authorization, open label registry study in 800 patients treated with ILUVIEN. Due to its post market safety surveillance not showing any unexpected safety signals, the Company requested and received approval to modify its protocol to cap enrollment in the study. Enrollment was completed with 562 patients enrolled in this study. The Company anticipates this study to be completed in early 2020. The Company commercially markets ILUVIEN in the U.S., Germany, the United Kingdom, Portugal, Austria and Ireland. In addition, the Company has entered into various agreements under which distributors provide or will provide regulatory, reimbursement or sales and marketing support for ILUVIEN in France, Italy, Spain, Australia, New Zealand, Canada and several countries in the Middle East. In 2016, the Company’s Middle East distributor launched ILUVIEN and initiated named patient sales in the United Arab Emirates. The Company’s Italian distributor launched ILUVIEN in Italy in 2017. The Company’s Spanish distributor began selling on a named patient basis in 2017 and is currently pursuing reimbursement at the national level. The Company’s French and Canadian distributors are currently pursuing reimbursement in their respective countries. As of December 31, 2018, the Company has recognized sales of ILUVIEN to the Company’s international distributors in the Middle East, France, Italy and Spain. In July 2017, the Company amended its license with EyePoint Pharmaceuticals US, Inc. (EyePoint), formerly known as pSivida US, Inc., for the technology underlying ILUVIEN to include the treatment of uveitis, including non-infectious posterior uveitis (NIPU) in Europe, the Middle East and Africa (Note 9). Uveitis is an inflammatory disease of the uveal tract, which is comprised of the iris, ciliary body and choroid, that can lead to severe vision loss and blindness. In December 2017, the Company filed an application for a new indication for ILUVIEN for NIPU in the 17 EEA countries where ILUVIEN is currently approved for the treatment of DME. The regulatory authorities requested additional follow-up data from the clinical trials to support the application. The Company submitted this additional follow-up data in October 2018. The Company expects to obtain approval of its application for NIPU in the first half of 2019, although the Company can provide no assurances that it can do so. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2018 | |
Accounting Policies [Abstract] | |
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES Use of Estimates in Financial Statements The financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America and, as such, include amounts based on informed estimates and judgments of management. Actual results could differ from those estimates. Principles of Consolidation The consolidated financial statements include the accounts of Alimera Sciences, Inc. and its wholly-owned subsidiaries. All significant inter-company balances have been eliminated in consolidation. Cash, Cash Equivalents and Restricted Cash Cash equivalents include highly liquid investments that are readily convertible into cash and have a maturity of 90 days or less when purchased. Generally, cash and cash equivalents held at financial institutions are in excess of federally insured limits. Cash and cash equivalents were $13,043,000 and $24,067,000 as of December 31, 2018 and 2017, respectively, with approximately 82.0% and 93.0% of these balances, respectively held in U.S.-based financial institutions. Product Revenue See Note 3 for expanded disclosures regarding the Company’s revenues and how the Company accounts for revenue. Accounts Receivable and Allowance for Doubtful Accounts Accounts receivable are generated through sales primarily to major pharmaceutical distributors, pharmacies, hospitals and wholesalers. The Company does not require collateral from its customers for accounts receivable. The carrying amount of accounts receivable is reduced by an allowance for doubtful accounts that reflects management ’ s best estimate of the amounts that will not be collected. In addition to reviewing delinquent accounts receivable, management considers many factors in estimating its general allowance, including historical data, experience, customer types, credit worthiness and economic trends. From time to time, management may adjust its assumptions for anticipated changes in any of those or other factors expected to affect collectability. A provision for doubtful accounts is charged to operations when management determines the accounts may become uncollectable. The Company writes off accounts receivable when management determines they are uncollectable and credits payments subsequently received on such receivables to bad debt expense in the period received. As of December 31, 2018 and 2017, the Company had no reserve for doubtful accounts. Inventory Inventories are stated at the lower of cost or net realizable value with cost determined under the first in, first out (FIFO) method. Included in inventory costs are component parts, work-in-progress and finished goods. The Company relies on third party manufacturers for the production of all inventory and does not capitalize any internal costs. The Company periodically reviews inventories for excess, obsolete or expiring inventory and writes down obsolete or otherwise unmarketable inventory to its estimated net realizable value. Intangible Assets The cost of intangible assets with determinable useful lives is amortized to reflect the pattern of economic benefits consumed, which approximates a straight-line basis, over the estimated periods benefited. The Company estimated the useful life of its intangible asset at approximately thirteen years (see Note 7). Property and Equipment Property and equipment are stated at cost. Additions and improvements are capitalized while repairs and maintenance are expensed. Depreciation is provided on the straight-line method over the useful life of the related assets beginning when the asset is placed in service. The estimated useful lives of the individual assets are as follows: furniture, fixtures and manufacturing equipment, five years ; automobiles, three years or the related lease life; software and information technology hardware, three years ; and office equipment and leasehold improvements are amortized over the shorter of their estimated useful lives or the related lease life. Impairment Property and equipment and definite lived intangible assets are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. When indicators of impairment are present, the Company evaluates the carrying amount of such assets in relation to the operating performance and future estimated undiscounted net cash flows expected to be generated by the assets. If such assets are considered to be impaired, the impairment to be recognized is measured by the amount by which the carrying amount of the assets exceeds the fair value of the assets. The assessment of the recoverability of assets will be impacted if estimated future operating cash flows are not achieved. Income Taxes The Company provides for income taxes based on pretax income and applicable tax rates available in the various jurisdictions in which it operates. Significant judgment is required in determining the provision for income taxes and income tax assets and liabilities, including evaluating uncertainties in the application of accounting principles and complex tax laws. Deferred income taxes are recorded for the expected tax consequences of temporary differences between the bases of assets and liabilities, as well as for loss and tax credit carryforwards for financial reporting purposes and amounts recognized for income tax purposes. A valuation allowance is recorded to reduce the Company’s deferred tax assets to the amount of future tax benefit that is more likely than not to be realized. The Company recognizes the tax benefit from an uncertain tax position only if it is more likely than not that the tax position will be sustained upon examination by the taxing authorities based on the technical merits of the position. The tax benefit recognized in the consolidated financial statements for a particular tax position is based on the largest benefit that is more likely than not to be realized. The amount of unrecognized tax benefits (UTBs) is adjusted as appropriate for changes in facts and circumstances, such as significant amendments to existing tax law, new regulations or interpretations by the taxing authorities, new information obtained during a tax examination, or resolution of an examination. The Company recognizes both accrued interest and penalties, where appropriate, related to UTBs in income tax expense. Research and Development Costs Research and development costs are expensed as incurred. Research and development expenses were $1,096,000 and $4,216,000 for 2018 and 2017, respectively. During 2017, the Company expensed $2,851,000 of in-process Research and Development Expense in connection with the New Collaboration Agreement (see Note 9). Stock-Based Compensation The Company has stock-based compensation plans under which various types of equity-based awards are granted, including restricted stock units (RSUs) and stock options. The fair values of RSUs and stock option awards, which are subject only to service conditions with graded vesting, are recognized as compensation expense, generally on a straight-line basis over a service period, net of estimated forfeitures. Compensation expense is recognized for all share-based awards based on the grant date fair value in accordance with the provisions of the Financial Accounting Standards Board (FASB) Accounting Standard Codification (ASC) 718, Compensation — Stock Compensation . The fair values for the options are estimated at the dates of grant using a Black-Scholes option-pricing model. Additionally, the Company sponsors an employee stock purchase plan (ESPP) under which U.S.-based employees may elect payroll withholdings to fund purchases of the Company’s stock at a discount. The Company estimates the fair value of the option to purchase shares of the Company’s common stock using the Black-Scholes valuation model and recognizes compensation expense in accordance with the provisions of ASC 718-50, Employee Share Purchase Plans . Derivative Financial Instruments The Company generally does not use derivative instruments to hedge exposures to cash flow or market risks. However, certain warrants to purchase Series A Convertible Preferred Stock or common stock that did not meet the requirements for classification as equity, in accordance with the Derivatives and Hedging Topic of the ASC, were classified as liabilities. In such instances, net-cash settlement is assumed for financial reporting purposes, even when the terms of the underlying contracts do not provide for a net-cash settlement. These warrants were considered derivative instruments at issuance because the warrant agreements (a) provided for settlement in Series A Convertible Preferred Shares or common shares at the option of the holder; (b) provided for future adjustment to the warrant exercise price for common shares; and (c) contained anti-dilution provisions whereby the number of shares for which the warrants were exercisable and/or the exercise price of the warrants were subject to change in the event of certain issuances of stock at prices below the then-effective exercise price of the warrants. Because the rights to exercise these warrants expired on October 1, 2017, the warrant exercise price no longer can be adjusted. The primary underlying risk exposure pertaining to the warrants was the change in fair value of the underlying common stock. Fair Value of Financial Instruments The carrying amounts of the Company’s financial instruments, including cash and cash equivalents and current assets and liabilities approximate their fair value because of their short maturities. The weighted average interest rate of the Company’s notes payable approximates the rate at which the Company could obtain alternative financing; therefore, the carrying amount of the note approximates the fair value. The Company uses the Black-Scholes option pricing model and assumptions that consider, among other variables, the fair value of the underlying stock, risk-free interest rate, volatility, expected life and dividend rates in estimating fair value for the warrants considered to be derivative instruments. Foreign Currency Translation The net assets of international subsidiaries where the local currencies have been determined to be the functional currencies are translated into U.S. dollars using applicable exchange rates. The U.S. dollar effects that arise from translating net assets of these subsidiaries at changing rates are recognized in a ccumulated other comprehensive loss and is the only adjustment recognized in a ccumulated other comprehensive loss . The earnings of these subsidiaries are translated into U.S. dollars using average exchange rates. Earnings Per Share (EPS) The Company follows ASC 260, Earnings Per Share (ASC 260), which requires the reporting of both basic and diluted earnings per share. Because the Company’s preferred stockholders participate in dividends equally with common stockholders (if the Company were to declare and pay dividends), the Company uses the two-class method to calculate EPS. Basic EPS is computed by dividing net income (loss) available to stockholders by the weighted average number shares outstanding for the period. Diluted EPS is calculated in accordance with ASC 260 by adjusting weighted average shares outstanding for the dilutive effect of common stock options, restricted stock units and warrants. The Company had net income available to stockholders for 2018 due to the gain on extinguishment of preferred stock (Note 12). Basic and diluted earnings per share attributable to common and participating shares of common stock for 2018 and 2017 were as follows: Years Ended December 31, 2018 2017 (In thousands, except share and per share data) Net income (loss) available to stockholders $ 21,948 $ (22,001 ) Allocation of undistributed earnings (loss): Earnings (loss) attributable to common stock $ 17,459 $ (22,001 ) Earnings attributable to participating securities $ 4,489 $ — Basic shares: Weighted average common shares 70,002,901 66,993,649 Weighted average participating shares 17,999,307 — Total basic weighted average shares 88,002,208 66,993,649 Diluted shares: Weighted average common shares 70,002,901 66,993,649 Dilutive weighted average shares 735,580 — Total dilutive weighted common shares 70,738,481 66,993,649 Weighted average participating shares 17,999,307 — Total dilutive weighted average shares 88,737,788 66,993,649 Basic EPS $ 0.25 $ (0.33 ) Diluted EPS $ 0.25 $ (0.33 ) Common stock equivalent securities that would potentially dilute basic EPS in the future, but were not included in the computation of diluted EPS because they were either classified as participating or would have been anti-dilutive, were as follows: Years Ended December 31, 2018 2017 Series A convertible preferred stock — 9,022,556 Series B convertible preferred stock — 8,416,251 Common stock warrants 1,795,663 1,795,663 Stock options 12,447,355 11,595,510 Restricted stock units — 839,285 Total 14,243,018 31,669,265 Reporting Segments The Company determines segments in accordance with its internal operating structure. The Company’s chief operating decision maker is the Chief Executive Officer (CEO). While the CEO is apprised of a variety of financial metrics and information, the business is principally managed and organized based upon geographic and regulatory environment. Each segment is separately managed and is evaluated primarily on net loss from operations adjusted for certain non-cash items, such as stock-based compensation expense and depreciation and amortization. The Company does not report balance sheet information by segment because it is not reviewed by the Company’s chief operating decision maker. The Company has three reportable segments, U.S., International and Other. See Note 18. Adoption of New Accounting Standards In May 2014, the Financial Accounting Standards Board (FASB) issued Accounting Standards Update (ASU) 2014-09, Revenue from Contracts with Customers (Topic 606) , which amends the guidance for the recognition of revenue from contracts with customers to transfer goods and services. The FASB subsequently issued an additional, clarifying ASU to address issues arising from implementation of the new revenue recognition standard, which became effective for interim and annual periods beginning on January 1, 2018. The new standard was required to be adopted using either a full-retrospective or a modified-retrospective approach. The Company adopted the new revenue guidance on January 1, 2018 using the modified-retrospective approach. The Company elected the practical expedient to apply the new revenue standard only to contracts that were not completed as of January 1, 2018. Adoption did not have a material impact on the Company’s financial statements on an ongoing basis. See Note 3 for additional information regarding the Company’s revenues and how the company accounts for revenue. In August 2016, the FASB issued ASU 2016-15, Classification of Certain Cash Receipts and Cash Payments (Topic 230) . ASU 2016-15 is intended to add or clarify guidance on the classification of certain cash receipts and payments in the statement of cash flows and to eliminate the diversity in practice related to such classifications. The standard is effective for annual reporting periods beginning after December 15, 2017, with early adoption permitted. The Company adopted this standard effective January 1, 2018, and the adoption of this guidance did not have a material impact on the Company’s financial statements. In November 2016, the FASB issued ASU 2016-18, Statement of Cash Flows (Topic 230) - Restricted Cash . ASU 2016-18 requires a statement of cash flows to explain the change during the period in the total of cash, cash equivalents and amounts generally described as restricted cash or restricted cash equivalents. Amounts generally described as restricted cash and restricted cash equivalents should be included with cash and cash equivalents when reconciling the beginning-of-period and end-of-period total amounts shown on the statement of cash flows. The standard is effective for interim and annual reporting periods beginning after December 15, 2017, with early adoption permitted. The Company adopted this standard effective January 1, 2018, and the adoption of this guidance did not have a material impact on the Company’s financial statements. The Company’s condensed consolidated statement of cash flows for the year ended December 31, 2017 has been reclassified for this ASU. In May 2017, the FASB issued ASU No. 2017-09, Compensation - Stock Compensation (Topic 718): Scope Modification Accounting . The new standard clarifies when changes to the terms or conditions of a share-based payment award must be accounted for as modifications. This standard became effective on January 1, 2018, and the Company adopted it on that date. The adoption of this guidance did not have a material impact on the Company’s financial statements. Accounting Standards Issued but Not Yet Effective In February 2016, the FASB issued ASU 2016-02, Leases (ASC 842) , to increase transparency and comparability among organizations for lease recognition and disclosure. ASU 2016-02 requires lessees to recognize lease assets and lease liabilities on the balance sheet, while recognizing expenses on the income statements in a manner similar to current guidance. ASU 2016-02 is effective for fiscal years beginning after December 15, 2018, including interim periods within those fiscal years, with early adoption permitted. The Company did not early adopt this standard and therefore the standard will be effective for the Company in the first quarter of 2019. ASU 2016-02 requires that leases be recognized and measured as of the earliest period presented, using a modified retrospective approach, with all periods presented being adjusted and presented under the new standard. In July 2018, the FASB issued ASU 2018-11, Leases (ASC 842) : Targeted Improvements, which provides companies an optional adoption method to ASU 2016-02 whereby a company does not have to adjust comparative period financial statements for the new standard. The Company will adopt this ASU on January 1, 2019 and will not restate comparative periods. The Company is substantially complete with its implementation plan. The Company plans to elect the transition package of three practical expedients permitted within the standard. In accordance with the package of practical expedients, the Company will not reassess initial direct costs, lease classification, or whether its contracts contain or are leases. The Company also made an accounting policy election to not recognize right-of-use assets and liabilities for leases with a term of 12 months or less, unless the leases include options to renew or purchase the underlying asset that are reasonably certain to be exercised. Based on the Company’s lease portfolio as of December 31, 2018, the Company plans to recognize an operating lease liability and related right-of-use asset on our balance sheet of approximately $1,250,000 , which represents the present value of our future minimum lease payments related to operating leases, primarily related to leases of real estate. The Company expects the deferred tax impacts of the adjustment to be nominal. In February 2018, the FASB issued ASU 2018-02, Reclassification of Certain Tax Effects from Accumulated Other Comprehensive Income , to allow reclassification from accumulated other comprehensive income to retained earnings for stranded tax effects resulting from the Tax Cuts and Jobs Act. Upon adoption of the ASU, entities will be required to describe the accounting policy for releasing income tax effects from accumulated other comprehensive income. The standard is required to be adopted for periods beginning after December 15, 2018, with early adoption available. The Company will adopt this standard effective January 1, 2019, and the Company does not believe the adoption of this standard will have a material impact on the Company’s financial statements. In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments - Credit losses (Topic 326): Measurement of Credit Losses on Financial Instruments . This ASU replaces the current incurred loss impairment methodology for financial assets measured at amortized cost with a methodology that reflects expected credit losses and requires consideration of a broader range of reasonable and supportable information, including forecasted information, to develop credit loss estimates. The standard is effective for annual periods beginning after December 15, 2019, including interim periods within those annual periods, with early adoption available. The Company has implemented process controls and systems to ensure compliance with this standard. The Company is in the process of determining the effect that the adoption will have on its financial statements. In June 2018, the FASB issued ASU No. 2018-07, Stock-based Compensation: Improvements to Nonemployee Share-based Payment Accounting , which amends the existing accounting standards for share-based payments to nonemployees. This ASU aligns much of the guidance on measuring and classifying nonemployee awards with that of awards to employees. Under the new guidance, the measurement of nonemployee equity awards is fixed on the grant date. Entities will apply the ASU by recognizing a cumulative-effect adjustment to retained earnings as of the beginning of the annual period of adoption. The Company will adopt this standard effective January 1, 2019, and the Company does not believe the adoption of this standard will have a material impact on the Company’s financial statements. |
Revenue Recognition
Revenue Recognition | 12 Months Ended |
Dec. 31, 2018 | |
Revenue from Contract with Customer [Abstract] | |
Revenue Recognition | REVENUE RECOGNITION Net Revenue The Company sells its products to major pharmaceutical distributors, pharmacies, hospitals and wholesalers (collectively, its Customers). In addition to distribution agreements with Customers, the Company enters into arrangements with healthcare providers and payors that provide for government-mandated and/or privately-negotiated rebates, chargebacks, and discounts with respect to the purchase of the Company’s products. All of the Company’s current contracts have a single performance obligation, as the promise to transfer the individual goods is not separately identifiable from other promises in the contracts and is, therefore, not distinct. Currently, all of the Company’s revenue is derived from product sales. The Company recognizes revenues from product sales at a point in time when the Customer obtains control, typically upon delivery. The Company accrues for fulfillment costs when the related revenue is recognized. Taxes collected from Customers relating to product sales and remitted to governmental authorities are excluded from revenues. As of December 31, 2018 and 2017, the Company had received a total of $1,000,000 and $500,000 , respectively, of payments that it has not recognized as revenue based on the Company’s analysis in connection with Topic 606. These deferred revenues are included as a component of other non-current liabilities on the Company’s balance sheets. Estimates of Variable Consideration Revenues from product sales are recorded at the net sales price (transaction price), which includes estimates of variable consideration for reserves related to statutory rebates to State Medicaid and other government agencies; commercial rebates and fees to Managed Care Organizations (MCOs), Group Purchasing Organizations (GPOs), distributors, and specialty pharmacies; product returns; sales discounts (including trade discounts); distributor costs; wholesaler chargebacks; and allowances for patient assistance programs relating to the Company’s sales of its products. These reserves are based on estimates of the amounts earned or to be claimed on the related sales. Management’s estimates take into consideration historical experience, current contractual and statutory requirements, specific known market events and trends, industry data, and Customer buying and payment patterns. Overall, these reserves reflect the Company’s best estimates of the amount of consideration to which it is entitled based on the terms of the contract. The amount of variable consideration included in the net sales price is limited to the amount that is probable not to result in a significant reversal in the amount of the cumulative revenue recognized in a future period. If actual results vary, the Company may adjust these estimates, which could have an effect on earnings in the period of adjustment. Consideration Payable to Customers Distribution service fees are payments issued to distributors for compliance with various contractually-defined inventory management practices or services provided to support patient access to a product. Distribution service fees reserves are based on the terms of each individual contract and are classified within accrued expenses and are recorded as a reduction of revenue. Product Returns The Company’s policies provide for product returns in the following circumstances: (a) expiration of shelf life on certain products; (b) product damaged while in the Customer’s possession; and (c) following product recalls. Generally, returns for expired product are accepted three months before and up to one year after the expiration date of the related product, and the related product is destroyed after it is returned. The Company may either refund the sales price paid by the Customer by issuance of a credit, or exchange the returned product with replacement inventory. The Company typically does not provide cash refunds. The Company estimates the proportion of recorded revenue that will result in a return by considering relevant factors, including historical returns experience, the estimated level of inventory in the distribution channel, the shelf life of products and product recalls, if any. The estimation process for product returns involves, in each case, a number of interrelating assumptions, which vary for each Customer. The Company estimates the amount of its product sales that may be returned by its Customers and records this estimate as a reduction of revenue from product sales in the period the related revenue is recognized, and because this returned product cannot be resold, there is no corresponding asset for product returns. To date, product returns have been minimal. Other Revenue The Company enters into agreements in which it licenses certain rights to its products to partner companies that act as distributors. The terms of these arrangements may include payment to the Company of one or more of the following: non-refundable, up-front license fees; development, regulatory and commercial milestone payments; payments for manufacturing supply services the Company provides; and a revenue share on net sales of licensed products. Each of these payments is recognized as other revenues. As part of the accounting for these arrangements, the Company must develop estimates that require judgment to determine the stand-alone selling price for each performance obligation identified in the contract. Performance obligations are promises in a contract to transfer a distinct good or service to the Customer, and the Company recognizes revenue when, or as, performance obligations are satisfied. The Company uses key assumptions to determine the stand-alone selling price; these assumptions may include forecasted revenues, development timelines, reimbursement rates for personnel costs, discount rates and probabilities of technical, regulatory and commercial success. Certain of these agreements include consideration in the form of milestone payments. At the inception of each arrangement that includes milestone payments, the Company evaluates the recognition of milestone payments. Typically, milestone payments are associated with events that are not entirely within the control of the Company or the licensee, such as regulatory approvals; are included in the transaction price; and are subject to a constraint until it is probable that there will not be a significant revenue reversal, typically upon achievement of the milestone. At the end of each reporting period, the Company re-evaluates the probability of achievement of such milestones and any related constraint, and if necessary, adjusts its estimate of the overall transaction price. Customer Payment Obligations The Company receives payments from its Customers based on billing schedules established in each contract, which vary across the Company’s locations, but generally range between 30 to 120 days. Occasionally, the timing of receipt of payment for the Company’s international Customers can be extended. Amounts are recorded as accounts receivable when the Company’s right to consideration is unconditional. The Company does not assess whether a contract has a significant financing component if the expectation is that the Customer will pay for the product or services in one year or less of receiving those products or services. |
Going Concern
Going Concern | 12 Months Ended |
Dec. 31, 2018 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
GOING CONCERN | GOING CONCERN The accompanying consolidated financial statements have been prepared on a going concern basis, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. The consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty. To date the Company has incurred recurring losses, negative cash flow from operations and has accumulated a deficit of $377,127,000 from the Company’s inception through December 31, 2018 . As of December 31, 2018 , the Company had approximately $13,043,000 in cash and cash equivalents. The Company’s ability to achieve profitability and positive cash flow depends on its ability to increase revenue and contain its expenses. Further, the Company must maintain compliance with the debt covenants of its $40,000,000 Loan and Security Agreement dated January 5, 2018 with Solar Capital Ltd. as Collateral Agent, and the parties signing the 2018 Loan Agreement from time to time as Lenders, including Solar Capital in its capacity as a Lender (see Note 10). In management’s opinion, the uncertainty regarding future revenues raises substantial doubt about the Company’s ability to continue as a going concern without access to additional debt and/or equity financing, over the course of the next twelve months. To meet the Company’s future working capital needs, the Company may need to raise additional debt or equity financing. While the Company has historically been able to raise additional capital through issuance of equity and/or debt financing, and while the Company has implemented a plan to control its expenses in order to satisfy its obligations due within one year from the date of issuance of these financial statements, the Company cannot guarantee that it will be able to maintain debt compliance, raise additional equity, contain expenses, or increase revenue. Accordingly, there is substantial doubt about the Company’s ability to continue as a going concern within one year after these financial statements are issued. |
Inventory
Inventory | 12 Months Ended |
Dec. 31, 2018 | |
Inventory Disclosure [Abstract] | |
INVENTORY | INVENTORY Inventory consisted of the following: December 31, 2018 2017 (In thousands) Component parts (1) $ 129 $ 404 Work-in-process (2) 924 587 Finished goods 1,352 517 Total inventory 2,405 1,508 (1) Component parts inventory consisted of manufactured components of the ILUVIEN applicator. (2) Work-in-process consisted of completed units of ILUVIEN that are undergoing, but have not completed, quality assurance testing as required by U.S. or EEA regulatory authorities. |
Property and Equipment
Property and Equipment | 12 Months Ended |
Dec. 31, 2018 | |
Property, Plant and Equipment [Abstract] | |
PROPERTY AND EQUIPMENT | PROPERTY AND EQUIPMENT Property and equipment consisted of the following: December 31, 2018 2017 (In thousands) Furniture and fixtures $ 392 $ 392 Office equipment 869 864 Automobiles 870 663 Software 1,275 1,122 Leasehold improvements 474 482 Manufacturing equipment 1,087 1,088 Total property and equipment 4,967 4,611 Less accumulated depreciation and amortization (3,612 ) (3,201 ) Property and equipment — net $ 1,355 $ 1,410 Depreciation and amortization expense associated with property and equipment totaled $705,000 and $744,000 for the years ended December 31, 2018 and 2017 , respectively. |
Intangible Assets
Intangible Assets | 12 Months Ended |
Dec. 31, 2018 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
INTANGIBLE ASSETS | INTANGIBLE ASSET As a result of the U.S. Food and Drug Administration ’ s (FDA) approval of ILUVIEN in September 2014, the Company was required to pay EyePoint a milestone payment of $25,000,000 (the EyePoint Milestone Payment) in October 2014 (see Note 9). The gross carrying amount of the intangible asset is $25,000,000 , which is being amortized over approximately 13 years from the acquisition date. The net book value of the intangible asset was $16,723,000 and $18,664,000 as of December 31, 2018 and 2017, respectively, and amortization expense was $1,940,000 for both the years ended December 31, 2018 and 2017, respectively. The estimated remaining amortization as of December 31, 2018 is as follows (in thousands): Years Ending December 31 2019 $ 1,940 2020 1,946 2021 1,940 2022 1,940 2023 1,940 Thereafter 7,017 Total $ 16,723 |
Accrued Expenses
Accrued Expenses | 12 Months Ended |
Dec. 31, 2018 | |
Payables and Accruals [Abstract] | |
ACCRUED EXPENSES | ACCRUED EXPENSES Accrued expenses consisted of the following: December 31, 2018 2017 (In thousands) Accrued clinical investigator expenses $ 781 $ 696 Accrued compensation expenses 1,427 511 Accrued rebate, chargeback and other revenue reserves 346 305 Accrued End of Term Payment (see Note 10) — 1,400 Other accrued expenses 1,089 670 Total accrued expenses $ 3,643 $ 3,582 |
License Agreements
License Agreements | 12 Months Ended |
Dec. 31, 2018 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
LICENSE AGREEMENTS | LICENSE AGREEMENTS EyePoint Agreement In February 2005, the Company entered into an agreement with EyePoint (formerly known as pSivida US, Inc.) for the use of fluocinolone acetonide (FAc) in EyePoint’s proprietary insert technology. This agreement was subsequently amended a number of times (as amended, the EyePoint Agreement). The EyePoint Agreement provides the Company with a worldwide exclusive license to utilize certain underlying technology used in the development and commercialization of ILUVIEN. 2008 Amended and Restated Collaboration Agreement Pursuant to the payment terms of the 2008 Amended and Restated Agreement (the 2008 Agreement), the Company was required to share with EyePoint 20% of the net profits of ILUVIEN, determined on a cash basis, and 33% of any lump sum milestone payments received from a sub-licensee of ILUVIEN. In connection with this Agreement, the Company was entitled to recover out of EyePoint’s share of the net profits of ILUVIEN, 20% of ILUVIEN’s commercialization costs (as defined in the EyePoint Agreement) that were incurred prior to product profitability. (The Company’s future rights to recover these amounts from EyePoint are referred to as the Future Offset.) In connection with the New Collaboration Agreement discussed below, the Future Offset was further amended. New Collaboration Agreement - Second Amended and Restated Collaboration Agreement On July 10, 2017, the Company and EyePoint entered into a Second Amended and Restated Collaboration Agreement (the New Collaboration Agreement), which amends and restates the EyePoint Agreement. Prior to entering into the New Collaboration Agreement, the Company held the worldwide license from EyePoint for the use of EyePoint’s proprietary insert technology for the treatment of all ocular diseases other than uveitis. The New Collaboration Agreement expands the license to include uveitis, including NIPU, in Europe, the Middle East and Africa and also allows the Company to pursue an indication for posterior uveitis for ILUVIEN in those territories. The New Collaboration Agreement converted the Company’s obligation to share 20% of its net profits to a royalty payable on global net revenues of ILUVIEN. The Company began paying a 2% royalty on net revenues and other related consideration to EyePoint on July 1, 2017. This royalty amount increased to 6% effective December 12, 2018. Pursuant to the New Collaboration Agreement the Company is required to pay an additional 2% royalty on global net revenues and other related consideration in excess of $75,000,000 in any year. During 2018, the Company recognized approximately $998,000 of royalty expense, which is included in cost of goods sold, excluding depreciation and amortization. As of December 31, 2018, approximately $428,000 of this royalty expense was included in the Company’s accounts payable. During 2017, the Company recognized approximately $621,000 of royalty and profit share expense. In connection with the New Collaboration Agreement, the Company and EyePoint first agreed to cap the Future Offset amount at $25,000,000 as of June 30, 2017 and the Company agreed to forgive $10,000,000 of the total $25,000,000 of the Future Offset at the July 10, 2017 amendment date. Following the signing of the New Collaboration Agreement, the Company retains a right to recover up to $15,000,000 of the Future Offset. Due to the uncertainty of future net profits, the Company has fully reserved the Future Offset in these financial statements. As of December 31, 2018, the balance of the Future Offset was approximately $14,937,000 . The Company will be able to recover this as a reduction of future royalties as follows: • In the first two years following the increase in royalty amount to 6% , the royalty will be reduced to 4% for net revenues and other related consideration up to $75,000,000 annually and 5% for net revenues and other related consideration in excess of $75,000,000 on an annual basis; and • Beginning with the third year following the increase in royalty amount to 6% , the royalty will be reduced to approximately 5.2% for net revenues and other related consideration up to $75,000,000 annually and to approximately 6.8% for net revenues and other related consideration in excess of $75,000,000 on an annual basis. The Company will forgive up to $5,000,000 of the remaining $15,000,000 of Future Offsets upon the earlier of the approval of ILUVIEN for posterior uveitis in any EU country or January 1, 2020, unless certain conditions under the New Collaboration Agreement are not met. The Company expects that it will obtain approval of its application for NIPU in the first half of 2019. If the amounts recoverable by the Company associated with the Future Offsets are less than $5,000,000 at that time, the Company will pay EyePoint the difference in cash. The Company valued the New Collaboration Agreement utilizing a present value analysis at approximately $2,851,000 . Possible Reversion of the Company’s License Rights to EyePoint The Company’s license rights to EyePoint’s proprietary delivery device could revert to EyePoint if the Company were to: (i) fail twice to cure its breach of an obligation to make certain payments to EyePoint following receipt of written notice thereof; (ii) fail to cure other breaches of material terms of the EyePoint Agreement within 30 days after notice of such breaches or such longer period (up to 90 days) as may be reasonably necessary if the breach cannot be cured within such 30 -day period; (iii) file for protection under the bankruptcy laws, make an assignment for the benefit of creditors, appoint or suffer appointment of a receiver or trustee over its property, file a petition under any bankruptcy or insolvency act or have any such petition filed against it and such proceeding remains undismissed or unstayed for a period of more than 60 days; or (iv) notify EyePoint in writing of its decision to abandon its license with respect to a certain product using EyePoint’s proprietary insert technology. |
Loan Agreements
Loan Agreements | 12 Months Ended |
Dec. 31, 2018 | |
Debt Disclosure [Abstract] | |
LOAN AGREEMENTS | LOAN AGREEMENTS Hercules Loan Agreement In April 2014, Alimera Sciences Limited (Alimera UK), a subsidiary of the Company, entered into a loan and security agreement (Hercules Loan Agreement) with Hercules Capital, Inc. (Hercules) providing for a term loan of up to $35,000,000 (Hercules Loan). The Company amended the Hercules Loan Agreement several times. On October 20, 2016 Alimera UK and Hercules entered into a fourth amendment to the Hercules Loan Agreement (the Fourth Loan Amendment), which provided the operative loan agreement terms during 2017. On January 5, 2018 the Company paid off the Hercules Loan on behalf of Alimera UK. The Fourth Loan Amendment provided for interest only payments that were scheduled through November 30, 2018. Pursuant to the Fourth Loan Amendment, interest on the Hercules Loan accrued at a floating per annum rate equal the greater of (i) 11.0% and (ii) the sum of (A) 11.0% plus (B) the prime rate as reported in The Wall Street Journal, or if not reported, the prime rate most recently reported in The Wall Street Journal, minus 3.5% . In addition to the interest described above, the principal balance of the Hercules Loan bore “payment-in kind” interest at the rate of 1.0% (PIK Interest), which PIK Interest was to be added to the outstanding principal balance of the Hercules Loan. The interest rate on the Hercules Loan was 12.0% as of December 31, 2017. Under the Hercules Loan Agreement as amended by the Fourth Loan Amendment, any principal prepayment of the Hercules loan triggered a prepayment penalty based on when the prepayment occurred. Because the Company prepaid the Hercules Loan Agreement on January 5, 2018, the Company paid 2.0% of the principal amount repaid, or $709,000 , which is included in loss on early extinguishment of debt for 2018. Before Alimera UK entered into the Fourth Loan Agreement, Alimera UK was already obligated to pay an end of term payment of $1,400,000 , which was paid when the Company paid off the Hercules loan on January 5, 2018. 2014 Warrant In connection with Alimera UK entering into the 2014 Loan Agreement, the Company issued a warrant that granted Hercules the right to purchase up to 285,016 shares of the Company’s common stock at an exercise price of $6.14 per share (the 2014 Warrant). The Company amended the 2014 Warrant a number of times to increase the number of shares issuable upon exercise to 1,258,993 and decrease the exercise price to $1.39 per share. The right to exercise this warrant expires on November 2, 2020. 2016 Warrant In connection with Alimera UK entering into the Fourth Loan Amendment, the Company agreed to issue a new warrant to Hercules (the 2016 Warrant) that granted Hercules the right to purchase up to 458,716 shares of the Company’s common stock at an exercise price of $1.09 per share. The right to exercise this warrant expires on October 20, 2021. Solar Capital Loan Agreement On January 5, 2018, the Company entered into a $40,000,000 Loan and Security Agreement (2018 Loan Agreement) with Solar Capital Ltd. (Solar Capital), as Collateral Agent (Agent), and the parties signing the 2018 Loan Agreement from time to time as Lenders, including Solar Capital in its capacity as a Lender (collectively, the Lenders). Under the 2018 Loan Agreement, the Company borrowed the entire $40,000,000 as a term loan that matures on July 1, 2022. The Company used the proceeds of the term loan to refinance the Hercules Loan Agreement and pay related expenses. The Company expects to use the remaining loan proceeds to provide additional working capital for general corporate purposes. Interest on the 2018 Loan Agreement is payable at one-month LIBOR plus 7.65% per annum. The 2018 Loan Agreement provides for interest only payments for the first 30 months ending on July 1, 2020, followed by 24 months of payments of principal and interest. If the Company meets certain revenue thresholds and no event of default shall have occurred and is continuing, the Company can extend the interest only period an additional six months ending on January 1, 2021, followed by 18 months of payments of principal and interest. As of December 31, 2018, the interest rate on the 2018 Loan Agreement was approximately 10.0% . As part of the fees and expenses incurred in conjunction with the 2018 Loan Agreement discussed above, the Company paid Solar Capital a $400,000 fee at closing. The Company is obligated to pay a $1,800,000 fee upon repayment of the term loan in full ( $2,000,000 if the interest only period has been extended to 36 months). The Company may elect to prepay the outstanding principal balance of the 2018 Loan Agreement in increments of $10,000,000 or more. The Company must pay a prepayment premium upon any prepayment of the 2018 Loan Agreement before its maturity date, whether by mandatory or voluntary prepayment, acceleration or otherwise, equal to: a. 2.00% of the principal amount prepaid for a prepayment made on or after January 5, 2018 through and including January 5, 2019; b. 1.00% of the principal amount prepaid for a prepayment made after January 5, 2019 through and including January 5, 2020; and c. 0.50% of the principal amount prepaid for a prepayment made after January 5, 2020 and greater than 30 days before the maturity date. The Company is also obligated to pay additional fees under the Exit Fee Agreement (Exit Fee Agreement) dated as of January 5, 2018 by and among the Company, Solar Capital as Agent, and the Lenders. The Exit Fee Agreement survives the termination of the 2018 Loan Agreement and has a term of 10 years. The Company is obligated to pay up to, but no more than, $2,000,000 in fees under the Exit Fee Agreement. Specifically, the Company is obligated to pay an exit fee of $2,000,000 on a “change in control” (as defined in the Exit Fee Agreement). To the extent that Alimera has not already paid the $2,000,000 fee, the Company is also obligated to pay a fee of $1,000,000 on achieving each of the following milestones: a. first, if the Company achieves revenues of $80,000,000 or more from the sale of its ILUVIEN product in the ordinary course of business to third party customers, measured on a trailing 12-month basis during the term of the agreement, tested at the end of each month; and b. second, if the Company achieves revenues of $100,000,000 or more from the sale of its ILUVIEN product in the ordinary course of business to third party customers, measured in the same manner. The Company agreed, for itself and its subsidiaries, to customary affirmative and negative covenants and events of default in connection with the 2018 Loan Agreement. The occurrence of an event of default could result in the acceleration of the Company’s obligations under the 2018 Loan Agreement and an increase to the applicable interest rate, and would permit Solar Capital to exercise remedies with respect to the collateral under the 2018 Loan Agreement. The Company’s obligations to Agent and the Lenders are secured by a first priority security interest in substantially all of the assets, excluding intellectual property, of the Company and its wholly owned subsidiary, Alimera Sciences (DE), LLC (Alimera DE), which is a guarantor of the loan, provided that only 65% of the voting interests in AS C.V., a Dutch subsidiary owned by the Company and Alimera DE, are pledged to the Lenders, and no assets or equity interests in the direct or indirect subsidiaries of AS C.V. are subject to the Lenders’ security interests. The Lenders do, however, maintain a negative pledge on the property of the Company and all of its subsidiaries, including the Company’s intellectual property, requiring the Lenders’ consent for any liens (other than typical permitted liens) on or the sale of such property. Extinguishment of Debt In accordance with the guidance in ASC 470-50, Debt , the Company accounted for the extinguishment of the Hercules Loan Agreement as an extinguishment and recognized a loss on early extinguishment of debt of approximately $1,766,000 within the consolidated statements of operations for 2018. The loss on early extinguishment consisted primarily of the early termination fee paid to Hercules and unamortized debt discounts including the remaining portion of warrant values and debt issuance costs. Fair Value of Debt As of December 31, 2018 and 2017, the weighted average interest rates of the Company’s notes payable approximate the rate at which the Company could obtain alternative financing and the fair value of the warrants that were issued in connection with the Company’s notes payable are immaterial. Therefore, the carrying amount of the notes approximated their fair value at December 31, 2018 and 2017. |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2018 | |
Commitments and Contingencies Disclosure [Abstract] | |
COMMITMENTS AND CONTINGENCIES | COMMITMENTS AND CONTINGENCIES Term Note Payable Under the 2018 Loan Agreement with Solar Capital (see Note 10), as of December 31, 2018 , the Company was obligated to make future minimum principal payments, excluding the $1,800,000 fee that will be due upon repayment of the term loan in full, as follows: Years Ending December 31 (In thousands) 2019 $ — 2020 8,333 2021 20,000 2022 11,667 Total 40,000 Less unamortized repayment fee (1,296 ) Less unamortized deferred financing costs (831 ) Less current portion — Non-current portion $ 37,873 As of December 31, 2018 and 2017 , the Company had $345,000 and $363,000 accrued and unpaid interest payable under the 2018 Loan Agreement with Solar Capital and the Hercules Loan Agreement, respectively. These amounts are included in accounts payable on the Company’s Consolidated Balance Sheets. Operating Leases The Company leases office space and equipment under non-cancelable agreements accounted for as operating leases. The leases generally require that the Company pay taxes, maintenance and insurance. Management expects that in the normal course of business, leases that expire will be renewed or replaced by other leases. In August 2014, the Company signed a lease for office space in the U.S. through September 2021. In December 2014, Alimera UK signed a lease for office space in the United Kingdom through December 24, 2024, although the lease is cancellable after December 17, 2019. The lease has a contingent escalation clause based on inflation beginning in 2020. The Company also leases office space in Ireland, Germany and Portugal under leases that expire in June 2019, June 2021 and March 2020, respectively. As of December 31, 2018 , a schedule by year of future minimum payments under all of the Company’s operating leases is as follows: Years Ending December 31 (In thousands) 2019 $ 564 2020 421 2021 300 Total $ 1,285 Rent expense under all operating leases totaled approximately $509,000 and $499,000 for the years ended December 31, 2018 and 2017 , respectively. Capital Leases The Company leases equipment under capital leases. The property and equipment is capitalized at the lesser of fair market value or the present value of the minimum lease payments at the inception of the leases using the Company’s incremental borrowing rate. As of December 31, 2018 , a schedule by year of future minimum payments under capital leases, together with the present value of minimum lease payments, is as follows (in thousands): Years Ending December 31 (In thousands) 2019 $ 328 2020 297 2021 76 Total 701 Less amount representing interest (42 ) Less amount representing executory costs (118 ) Present value of minimum lease payments 541 Less current portion (236 ) Non-current portion $ 305 Property and equipment under capital leases, which are included in property and equipment (Note 6), consisted of the following: December 31, 2018 2017 (In thousands) Automobiles $ 870 $ 663 Office equipment 60 63 Less accumulated depreciation (315 ) (311 ) Total $ 615 $ 415 Depreciation expense associated with property and equipment under capital leases was approximately $281,000 and $172,000 for the years ended December 31, 2018 and 2017 , respectively. Significant Agreements In February 2010, the Company entered into an agreement with a third party manufacturer for the manufacture of the ILUVIEN implant, the assembly of the ILUVIEN applicator and the packaging of the completed ILUVIEN commercial product. The Company is responsible for supplying the ILUVIEN applicator and the active pharmaceutical ingredient. In accordance with the terms of the agreement, the Company must order at least 80% of the ILUVIEN units required in the U.S., Canada and the EEA from the third party manufacturer. This agreement had an initial term of six years. After that six -year term ended, the agreement automatically renewed for successive one -year periods. In February 2016, the Company and the third party manufacturer amended and restated this agreement to extend the term by five years, at which point the agreement will automatically renew for successive one -year periods unless either party delivers notice of non-renewal to the other party at least 12 months before the end of the term or any renewal term. In May 2013, the Company entered into an agreement with the first of three contract research organizations (CROs) for clinical and data management services to be performed in connection with the five -year, post-authorization, open label registry study in patients treated with ILUVIEN per the labeled indication in the EEA. Since May 2013, the company has entered into twelve additional agreements for work with these CROs. For the years ended December 31, 2018 and 2017 , the Company incurred $141,000 and $101,000 , respectively, of expense associated with these agreements. As of December 31, 2018 and 2017, $4,000 and $67,000 , respectively, is included in accrued expenses (Note 8). As of December 31, 2018, the Company expects to incur an additional $210,000 of expense associated with these agreements through December 31, 2019. Employment Agreements The Company is party to employment agreements with four executives. The agreements generally provide for annual salaries, bonuses and benefits and for the “at-will” employment of such executives. Effective January 1, 2019, the Company is party to four agreements with annual salaries ranging from $332,000 to $525,000 . If any of the agreements are terminated by the Company without cause, or by the employee for good reason, as defined in the agreements, the Company will be liable for one year to 18 months of salary and benefits. Certain other employees have general employment contracts that include stipulations regarding confidentiality, Company property, severance in an event of change of control and miscellaneous items. |
Preferred Stock
Preferred Stock | 12 Months Ended |
Dec. 31, 2018 | |
Equity [Abstract] | |
PREFERRED STOCK | PREFERRED STOCK Series A Convertible Preferred Stock On October 2, 2012, the Company closed its preferred stock financing in which it sold units consisting of 1,000,000 shares of Series A Convertible Preferred Stock (Series A Preferred Stock) and warrants to purchase 300,000 shares of Series A Preferred Stock for gross proceeds of $40,000,000 , prior to the payment of approximately $560,000 of related issuance costs. The powers, preferences and rights of the Series A Preferred Stock are set forth in the certificate of designation for the Series A Preferred Stock filed by the Company with the Delaware Secretary of State as part of the Company’s certificate of incorporation. Each share of Series A Preferred Stock is convertible into shares of the Company’s common stock at any time at the option of the holder at the rate equal to $40.00 divided by $2.66 (Conversion Price). The initial Conversion Price was subject to adjustment based on certain customary price-based anti-dilution adjustments. These adjustment features lapsed in September 2014. Each share of Series A Preferred Stock shall automatically be converted into shares of common stock at the then-effective Conversion Price upon the date on which the Company consummates an equity financing transaction pursuant to which the Company sells to one or more third party investors either (a) shares of common stock or (b) other equity securities that are convertible into shares of common stock and that have rights, preference or privileges, senior to or on a parity with, the Series A Preferred Stock, in each case having an as-converted per share of common stock price of not less than $10.00 and that results in total gross proceeds to the Company of at least $30,000,000 . The rights and preferences of Series A Preferred Stock also place limitations on the Company ’ s ability to declare or pay any dividend or distribution on any shares of capital stock. Each unit sold in the preferred stock financing included a warrant to purchase 0.30 shares of Series A Preferred Stock at an exercise price equal to $44.00 per share. At the election of the holder of a warrant, the warrant could have been exercised for the number of shares of common stock then issuable upon conversion of the Series A Preferred Stock that would otherwise be issued upon such exercise at the then-effective Conversion Price. The rights to exercise these warrants expired on October 1, 2017. These warrants were considered derivative instruments because the agreements provided for settlement in Series A Preferred Stock shares or common stock shares at the option of the holder, an adjustment to the warrant exercise price for common shares at some point in the future, and contain anti-dilution provisions whereby the number of shares for which the warrants were exercisable and/or the exercise price of the warrants was subject to change in the event of certain issuances of stock at prices below the then-effective exercise price of the warrants. Therefore, the warrants were recorded as a liability at issuance. The warrant anti-dilution provisions lapsed in September 2014. During 2017, the Company recorded a gain of $188,000 as a result of the change in fair value of the warrants In 2014, 6,015,037 shares of common stock were issued pursuant to the conversion of 400,000 shares of Series A Convertible Preferred Stock. As of December 31, 2018, there were 600,000 shares of Series A Convertible Preferred Stock issued and outstanding. Series B Convertible Preferred Stock On December 12, 2014, the Company closed a preferred stock financing in which it sold 8,291.873 shares of Series B Convertible Preferred Stock (Series B Preferred Stock) for a purchase price of $6,030 per share, or an aggregate purchase price of $50,000,000 , prior to the payment of approximately $432,000 of related issuance costs. The Company issued an additional 124.378 shares of Series B Preferred Stock as a subscription premium to the purchasers. On September 4, 2018, all of the outstanding shares of Series B Preferred Stock were exchanged for shares of Series C Convertible Preferred Stock (see below). The powers, preferences and rights of the Series B Preferred Stock were set forth in the certificate of designation for the Series B Preferred Stock filed by the Company with the Delaware Secretary of State as part of the Company’s certificate of incorporation. Each share of Series B Preferred Stock was convertible into 1,000 shares of the Company’s common stock at any time at the option of the holder, provided that the holder was prohibited from converting Series B Preferred Stock into shares of the Company’s common stock if, as a result of such conversion, the holder, together with its affiliates, would own more than 9.98% of the total number of shares of the Company’s common stock then issued and outstanding. The Series B Preferred Stock ranked junior to the Company’s existing Series A Preferred Stock and senior to the Company’s common stock, with respect to rights upon liquidation. The Series B Preferred Stock ranked junior to all existing and future indebtedness. Except as otherwise required by law (or with respect to approval of certain actions), the Series B Preferred Stock did not have voting rights. The Series B Preferred Stock was not redeemable at the option of the holder. The Series B Preferred Stock was not subject to any price-based or other anti-dilution protections and did not provide for any accruing dividends. The Company determined that the conversion option of the Series B Preferred Shares represented a beneficial conversion feature, as the conversion feature had intrinsic value to the holder on the commitment date as a result of the subscription premium. Therefore, the Company recorded a beneficial conversion feature of $750,000 as an increase in additional paid in capital. Because the Series B Preferred Stock was immediately convertible into common stock at the option of the holder at issuance, the Company immediately accreted the full value of the beneficial conversion feature to the carrying value of the Series B Preferred Stock on that date. On September 4, 2018, following the closing of the exchange of all outstanding shares of Series B Preferred Stock for shares of Series C Convertible Preferred Stock, the Company filed with the Delaware Secretary of State a Certificate of Elimination of Series B Convertible Preferred Stock of Alimera Sciences, Inc., which eliminated from the Company’s amended and restated certificate of incorporation, as amended, the Alimera Sciences, Inc. Certificate of Designation of Preferences, Rights and Limitations of Series B Convertible Preferred Stock. As a result, all shares of the Company’s preferred stock previously designated as Series B Convertible Preferred Stock were eliminated and returned to the status of authorized but unissued shares of preferred stock, without designation as to series. Series C Convertible Preferred Stock On September 4, 2018, the Company entered into and closed a Series B Preferred Stock Exchange Agreement (Exchange Agreement) with the holders of all of the outstanding approximately 8,416 shares of Series B Preferred Stock. Under the Exchange Agreement, the holders of Series B Preferred Stock exchanged their shares of Series B Preferred Stock for an aggregate of 10,150 shares of Series C Convertible Preferred Stock, par value $0.01 per share (Series C Preferred Stock). The powers, preferences and rights of the Series C Preferred Stock are set forth in the certificate of designation filed by the Company with the Delaware Secretary of State as part of the Company’s certificate of incorporation, as amended. All of the outstanding shares of Series B Preferred Stock were canceled in the exchange. The Company incurred approximately $122,000 in legal costs related to the Exchange Agreement. The 10,150 issued and outstanding shares of Series C Preferred Stock have an aggregate stated value of $10,150,000 and are convertible into shares of the Company’s common stock at $1.00 per share, or 10,150,000 shares of the Company’s common stock in total, at any time at the option of the holder, provided that the holder will be prohibited from converting shares of Series C Preferred Stock into shares of the Company’s common stock if, as a result of such conversion, the holder, together with its affiliates, would own more than 9.98% of the total number of shares of the Company’s common stock then issued and outstanding. The Series C Preferred Stock is not redeemable at the option of the holder. In the event of a liquidation, dissolution or winding up of the Company and in the event of certain mergers, tender offers and asset sales, the holders of the Series C Preferred Stock will receive the greater of (a) the liquidation preference equal to $10,150,000 in the aggregate, plus any declared but unpaid dividends, or (b) the amount such holders would receive had all shares of the Series C Preferred Stock been converted into the Company’s common stock immediately before such event. With respect to rights upon liquidation, the Series C Preferred Stock ranks junior to the Company’s Series A Preferred Stock and senior to the Company’s common stock. The Series C Preferred Stock ranks junior to all existing and future indebtedness. Except as otherwise required by law (or with respect to approval of certain actions), the Series C Preferred Stock does not have voting rights. The Series C Preferred Stock is not subject to any price-based anti-dilution protections and does not provide for any accruing dividends. The Company determined that the Exchange Agreement resulted in an extinguishment of the Series B Preferred Stock. As a result, the Company recognized a gain of $38,330,000 on the extinguishment of preferred stock during 2018. As of the transaction date, the Company made an assessment of the fair market value of the Series C Preferred Stock and calculated the value to be $11,239,000 , prior to the payment of approximately $122,000 of related transaction costs. This Company recorded this gain within stockholders’ equity and as an increase to earnings available to stockholders for 2018. The $38,330,000 gain on extinguishment of preferred stock was derived by the difference in the fair market value of the Series C Preferred Stock and the carrying value of the Series B Preferred Stock. |
Stock Incentive Plans
Stock Incentive Plans | 12 Months Ended |
Dec. 31, 2018 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
STOCK INCENTIVE PLANS | STOCK INCENTIVE PLANS The Company has stock option and stock incentive plans that provide for grants of shares to employees and grants of options to employees and directors to purchase shares of the Company’s common stock at exercise prices generally equal to the fair values of such stock at the dates of grant. Awards that can be granted under these plans include stock options, restricted stock units (RSUs) and restricted stock. The Company also has an employee stock purchase plan (see Note 17). Options granted to employees typically become exercisable over a four -year vesting period and have a ten -year contractual term. Initial options granted to directors typically vest over a four -year period and have a ten -year contractual term. Annual option grants to directors typically vest immediately and have a ten -year contractual term. Upon the exercise of stock options, the Company may issue the required shares out of authorized but unissued common stock or out of treasury stock at management’s discretion. A summary of stock option transactions under the plans are as follows: Years Ended December 31, 2018 2017 Options Weighted Average Exercise Price Options Weighted Average Exercise Price Options outstanding at beginning of period 11,595,510 $ 2.90 10,804,412 $ 3.22 Grants 2,111,375 1.07 2,336,300 1.25 Forfeitures (1,257,967 ) 2.54 (1,544,473 ) 2.63 Exercises (1,563 ) 1.06 (729 ) 1.49 Options outstanding at year end 12,447,355 2.63 11,595,510 2.90 Options exercisable at year end 9,138,544 3.09 8,085,064 3.25 Weighted average per share fair value of options granted during the year $ 0.71 $ 0.94 The following table provides additional information related to outstanding stock options, fully vested stock options, and stock options expected to vest as of December 31, 2018 : Shares Weighted Average Exercise Price Weighted Average Contractual Term Aggregate Intrinsic Value (In thousands) Outstanding 12,447,355 $ 2.63 6.25 years $ — Exercisable 9,138,544 3.09 5.37 years — Outstanding, vested and expected to vest 12,044,311 2.67 6.16 years — The Company estimated the fair value of options granted using the Black-Scholes option pricing model. Use of a valuation model requires the Company to make certain assumptions with respect to selected model inputs. Changes in these input variables would affect the amount of expense associated with equity-based compensation. Expected volatility is based on the historical volatility of the Company ’ s common shares over the expected term of the stock option grant. To estimate the expected term, the Company utilizes the “simplified” method for “plain vanilla” options as discussed within the SEC’s Statement of Accounting Bulletin 107. The Company intends to utilize the simplified method for the foreseeable future until more detailed information about exercise behavior will be more widely available. The risk-free interest rate is based on U.S. Treasury Daily Treasury Yield Curve Rates corresponding to the expected life assumed at the date of grant. Dividend yield is zero as there are no payments of dividends made or expected. The weighted-average assumptions used for option grants were as follows: Years Ended December 31, 2018 2017 Risk-free interest rate 2.63 % 2.06 % Volatility factor 72.60 % 90.49 % Grant date fair value of common stock options $ 0.71 $ 0.94 Weighted-average expected life 6.02 years 6.02 years Assumed forfeiture rate 10.00 % 10.00 % Employee stock-based compensation expense related to stock options recognized in accordance with ASC 718 was as follows: Years Ended December 31, 2018 2017 (In thousands) Sales and marketing $ 685 $ 907 Research, development and medical affairs 565 643 General and administrative 2,130 2,510 Total employee stock-based compensation expense related to stock options $ 3,380 $ 4,060 As of December 31, 2018, there was approximately $2,993,000 of total unrecognized compensation cost related to outstanding stock option awards that will be recognized over a weighted average period of 2.25 years. The total fair value of shares vested during 2018 was approximately $3,400,000 . The total estimated fair value of options granted during the years ended December 31, 2018 and 2017 was $2,268,000 and $2,186,000 , respectively. The total estimated intrinsic value of options exercised was less than $1,000 for both the years ended December 31, 2018 and 2017 , respectively. As of December 31, 2018, the Company was authorized to grant options to purchase up to an additional 263,498 shares under the 2010 Equity Incentive Plan. The Company’s 2010 Plan provides for annual increases in the number of shares available for issuance thereunder on the first day of each fiscal year equal to the lesser of: (1) 2,000,000 shares of common stock; (2) 4% of the shares of common stock outstanding at that time; and (3) such other amount as our board of directors may determine. On January 1, 2019, an additional 2,000,000 shares became available for future issuance under the 2010 Plan. These additional shares from the annual increase under the 2010 Plan are not included in the foregoing discussion. Restricted Stock Units A summary of RSU transactions under the plans are as follows: Years Ended December 31, 2018 2017 RSUs Weighted Average Grant Date Fair Value RSUs Weighted Average Grant Date Fair Value Restricted stock units outstanding at beginning of period 839,285 $ 1.21 — $ — Grants 1,091,712 1.15 964,720 1.21 Vested units (839,285 ) 1.21 — — Forfeitures (191,460 ) 1.15 (125,435 ) 1.18 Restricted stock units outstanding at year end 900,252 1.15 839,285 1.21 As of December 31, 2018, there was approximately $169,000 of total unrecognized compensation cost related to outstanding RSUs that will be recognized during the first quarter of 2019. Employee stock-based compensation expense related to RSUs recognized in accordance with ASC 718 was $1,002,000 and $883,000 for the years ended December 31, 2018, and 2017, respectively. |
Common Stock Warrants
Common Stock Warrants | 12 Months Ended |
Dec. 31, 2018 | |
Equity [Abstract] | |
COMMON STOCK WARRANTS | COMMON STOCK WARRANTS The Company has issued warrants to purchase common stock to various members of the board of directors, third parties for services, and lenders. Warrants to purchase a total of 1,795,663 shares of common stock were outstanding as of December 31, 2018 and 2017 . As of December 31, 2018, the exercise prices ranged from $1.09 to $11.00 per share. The warrants are exercisable for a period between 5 and 10 years from the issuance date. In connection with Alimera UK entering into the Hercules Loan Agreement (Note 10), the Company entered into the 2014 Warrant, which granted Hercules the right to purchase up to 285,016 shares of the Company’s common stock at an exercise price of $6.14 per share. The Company amended the 2014 Warrant a number of times to increase the number of shares issuable upon exercise to 1,258,993 and decrease the exercise price to $1.39 per share. The right to exercise this warrant expires on November 2, 2020. In connection with Alimera UK entering into the Fourth Loan Amendment with Hercules, the Company agreed to issue the 2016 Warrant, which granted Hercules the right to purchase up to 458,716 shares of the Company’s common stock at an exercise price of $1.09 per share. The right to exercise this warrant expires on October 20, 2021. |
Concentrations and Credit Risk
Concentrations and Credit Risk | 12 Months Ended |
Dec. 31, 2018 | |
Risks and Uncertainties [Abstract] | |
CONCENTRATIONS AND CREDIT RISK | CONCENTRATIONS AND CREDIT RISK For the years ended December 31, 2018 and 2017, there were three customers within the U.S. segment. Two of these customers, which are large pharmaceutical distributors, accounted for approximately 69% and 73% , respectively, of the Company ’ s total consolidated revenues. These two customers accounted for approximately 73% and 81% of the Company ’ s consolidated accounts receivable as of December 31, 2018 and 2017, respectively. For the years ended December 31, 2018 and 2017 one of the Company ’ s third-party manufacturers of ILUVIEN comprised approximately 13.7% and 10.5% , respectively, of the Company ’ s total purchases, and there were no other vendors that comprised more than 10% of the Company ’ s total purchases. The Company relies on a single manufacturer for ILUVIEN, a single manufacturer for the ILUVIEN applicator and a single active pharmaceutical ingredient manufacturer for ILUVIEN’s active pharmaceutical ingredient. |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2018 | |
Income Tax Disclosure [Abstract] | |
INCOME TAXES | INCOME TAXES On December 22, 2017, the United States enacted major tax reform legislation, Public Law No. 115-97, commonly referred to as the Tax Cuts and Jobs Act (2017 Tax Act). The more significant attributes of the 2017 Tax Act impose a repatriation tax on accumulated earnings of foreign subsidiaries, implement a territorial tax system together with a current tax on certain foreign earnings and lower the general corporate income tax rate to 21%. Following guidance provided by SEC Staff Accounting Bulletin No. 118, which in March 2018 was codified by the FASB in ASU 2018-05, Income Taxes (Topic 740) the Company remeasured certain net deferred and other tax liabilities based on the tax rate at which they are expected to reverse, which is now 21% instead of 35%. The net impact of the 2017 Tax Act was $0 due to a full valuation allowance recorded against the U.S. deferred tax assets. During 2018, the Company continued to analyze other provisions of the 2017 Tax Act and as of December 31, 2018, we have completed our accounting for the effects of the 2017 Tax Act. The components of net loss before taxes are as follows: Years Ended December 31, 2018 2017 (In thousands) United States $ (2,908 ) $ (1,890 ) Foreign (13,368 ) (19,948 ) Loss before provision for income taxes $ (16,276 ) $ (21,838 ) In accordance with ASC 740, the Company recognizes deferred tax assets and liabilities for temporary differences between the financial reporting basis and the tax basis of assets and liabilities at the enacted tax rates in effect for the year in which the differences are expected to reverse. The Company records a valuation allowance against the net deferred tax asset to reduce the net carrying value to an amount that is more likely than not to be realized. The provision for income taxes consists of the following components: Years Ended December 31, 2018 2017 (In thousands) Current expense (benefit): Federal $ — $ — State — — Foreign 759 255 Current income tax expense 759 255 Deferred expense (benefit): Federal 256 549 State 411 3,330 Foreign (654 ) (92 ) 13 3,787 Valuation allowance (666 ) (3,879 ) Deferred income tax benefit (653 ) (92 ) Total income tax expense $ 106 $ 163 The following summarizes activity related to the Company ’ s valuation allowance: Years Ended December 31, 2018 2017 (In thousands) Valuation allowance at beginning of period $ (41,485 ) $ (55,968 ) Income tax provision (666 ) (3,879 ) U.S. Tax Reform — 18,362 Valuation allowance at end of period $ (42,151 ) $ (41,485 ) Worldwide net deferred tax assets and liabilities are as follows: December 31, 2018 2017 Deferred tax assets (In thousands) Depreciation and amortization $ 55 $ 44 Other deferred tax assets 1,382 707 NOL carry-forwards 34,217 33,980 Research and development costs 813 1,340 Equity compensation 4,485 3,686 Collaboration agreement receivable reserves 2,381 2,256 Valuation allowance (42,151 ) (41,485 ) Total deferred tax assets $ 1,182 $ 528 A reconciliation from the federal statutory rate to the total provision for income taxes is as follows: Years Ended December 31, 2018 2017 Amount Percent Amount Percent (in thousands, except percentages) Federal tax benefit at statutory rate $ (3,463 ) 21.0 % $ (7,425 ) 34.0 % State tax — net of federal benefit 1 — (3,783 ) 17.3 Permanent items and other 528 (3.2 ) 686 (3.1 ) Foreign rate differential 2,946 (17.9 ) 6,880 (31.5 ) U.S. tax reform — — 18,362 (84.1 ) Deferred rate change (438 ) 2.7 (212 ) 1.0 Other (134 ) 0.8 138 (0.6 ) Change in valuation allowance 666 (4.0 ) (14,483 ) 66.3 Total tax expense (benefit) $ 106 (0.6 )% $ 163 (0.7 )% The change in state taxes in 2017, net of federal benefit, was a result of the Company filing additional state income tax returns in 2017. This resulted in approximately $3.8 million of state NOLs being generated. During 2018, there was no additional impact of the one-time, non-cash deferred rate change as a result of the 2017 Tax Act. The U.S. corporate tax rate change and state NOLs are fully offset by a valuation allowance recorded against U.S. federal and state income taxes; therefore, the overall impact of these items is zero to income tax expense. A rollforward of the Company’s uncertain tax positions is as follows: Years Ended December 31, 2018 2017 (In thousands) Balance of uncertain tax positions at beginning of period $ 52 $ 59 Gross increases - tax positions in current period 13 4 Gross increases - tax positions in prior period 10 — Gross decreases - tax positions in prior period (7 ) (11 ) Settlements — — Lapse of statute of limitations — — Balance of uncertain tax positions at end of period $ 68 $ 52 Included in the balance of unrecognized tax benefits as of December 31, 2018 and 2017 are approximately $68,000 and $52,000 , respectively, of tax benefits related to research and development tax credits. In accordance with ASC 740-10, such attributes are reduced to the amount that is expected to be recognized in the future. The Company does not accrue interest or penalties, as there is no risk of additional tax liability due to significant NOLs available. The Company does not expect any decreases to the unrecognized tax benefits within the next twelve months due to any lapses in statute of limitations. Tax years from 2014 to 2017 remain subject to examination in California, Georgia, Kentucky, Tennessee, Texas and on the federal level, with the exception of the assessment of NOL carry-forwards available for utilization, which can be examined for all years since 2009. The statute of limitations on these years will close when the NOLs expire or when the statute closes on the years in which the NOLs are utilized. Significant management judgment is involved in determining the provision for income taxes, deferred tax assets and liabilities, and any valuation allowance recorded against net deferred tax assets. Due to uncertainties with respect to the realization of U.S. deferred tax assets due to the history of operating losses, a valuation allowance has been established against the entire net U.S. deferred tax asset balance. The valuation allowance is based on management’s estimates of taxable income in the jurisdictions in which the Company operates and the period over which deferred tax assets will be recoverable. If actual results differ from these estimates or the Company adjusts these estimates in future periods, a change in the valuation allowance may be needed, which could materially impact the Company’s financial position and results of operations. As of December 31, 2018 and 2017 , the Company had federal net operating loss (NOL) carry-forwards of approximately $122,455,000 and $121,413,000 , and state NOL carry-forwards of approximately $153,333,000 , and $161,753,000 respectively, subject to further limitation based upon the final results of our Internal Revenue Code (IRC) sections 382 and 383 analyses. These NOLs are available to reduce future income unless otherwise taxable. If not utilized, the federal NOL carry-forwards will expire at various dates between 2029 and 2037, the Company’s federal NOL created in 2018 will carry forward indefinitely and the state NOL carry-forwards will expire at various dates between 2020 and 2038. Sections 382 and 383 of the Internal Revenue Code limit the annual use of NOL carry-forwards and tax credit carry-forwards, respectively, following an ownership change. NOL carry-forwards may be subject to annual limitations under IRC Section 382 (Section 382) (or comparable provisions of state law) if certain changes in ownership were to occur. The Company periodically evaluates its NOL carry-forwards and whether certain changes in ownership have occurred that would limit the Company’s ability to utilize a portion of its NOL carry-forwards. If it is determined that significant ownership changes have occurred since the Company generated its NOL carry-forwards, the Company may be subject to annual limitations on the use of these NOL carry-forwards under Section 382 (or comparable provisions of state law). The Company has determined that a Section 382 change in ownership occurred in late 2015. As a result of this change in ownership, the Company estimated that approximately $18.6 million of the Company ’ s federal NOLs and approximately $382,000 of federal tax credits generated prior to the change in ownership will not be utilized in the future. The Company is currently in the process of refining and finalizing these calculations, and upon finalization, will determine if a write-off is necessary. The reduction to the Company’s NOL deferred tax asset due to the annual Section 382 limitation and the NOL carryforward period would result in an offsetting reduction in valuation allowance recorded against the NOL deferred tax asset. As of December 31, 2018, the Company had cumulative book losses in foreign subsidiaries of approximately $126,648,000 . The Company has not recorded a deferred tax asset for the excess of tax over book basis in the stock of its foreign subsidiaries. The Company anticipates that its foreign subsidiaries will be profitable and have earnings in the future. Once the foreign subsidiaries do have earnings, the Company intends to indefinitely reinvest in its foreign subsidiaries all undistributed earnings of and original investments in such subsidiaries. As a result, the Company does not expect to record deferred tax liabilities in the future related to excesses of book over tax basis in the stock of its foreign subsidiaries in accordance with ASC 740-30-25. |
Employee Benefit Plans
Employee Benefit Plans | 12 Months Ended |
Dec. 31, 2018 | |
Retirement Benefits [Abstract] | |
EMPLOYEE BENEFIT PLANS | EMPLOYEE BENEFIT PLANS The Company has a salary deferral 401(k) plan that covers substantially all U.S. employees of the Company. The Company matches participant contributions subject to certain plan limitations. Compensation expense associated with the Company’s matching plan totaled $274,000 and $187,000 for the years ended December 31, 2018 and 2017 , respectively. The Company may also make an annual discretionary profit-sharing contribution. No such discretionary contributions were made during the years ended December 31, 2018 and 2017 , respectively. In April 2010, the Company established an Employee Stock Purchase Plan (the Purchase Plan). Under the Company’s Purchase Plan, eligible employees can participate and purchase common stock semi-annually through accumulated payroll deductions. The Purchase Plan is administered by the Company’s board of directors or a committee appointed by the Company’s board of directors. Under the Purchase Plan eligible employees may purchase stock at 85% of the lower of the fair market value of a share of common stock on the offering date or the exercise date. The Purchase Plan provides for two six -month purchase periods generally starting on the first trading day on or after October 31 and April 30 of each year. Eligible employees may contribute up to 15% of their eligible compensation. A participant may purchase a maximum of 2,500 shares of common stock per purchase period. The value of the shares purchased in any calendar year may not exceed $25,000 . The Purchase Plan was effective upon the completion of the Company’s initial public offering in 2010, at which time a total of 494,422 shares of the Company’s common stock were made available for sale. As of January 1 of each year, the number of available shares is automatically restored to the original level. A total of 91,649 and 79,733 shares of the Company’s common shares were acquired through the Purchase Plan during the years ended December 31, 2018 and 2017 , respectively. As such, on January 1, 2019 and 2018, respectively, an additional 91,649 and 79,733 shares became available for future issuance under the Purchase Plan. In accordance with ASC 718-50, the ability to purchase stock at 85% of the lower of the fair market value of a share of Common Stock on the offering date or the exercise date represents an option. The Company estimates the fair value of such options at the inception of each offering period using the Black-Scholes valuation model. In connection with the Purchase Plan, the Company recorded $31,000 and $38,000 of compensation expense for the years ended December 31, 2018 and 2017 , respectively. |
Segment Information
Segment Information | 12 Months Ended |
Dec. 31, 2018 | |
Segment Reporting [Abstract] | |
Segment Information | SEGMENT INFORMATION For the years ended December 31, 2018 and 2017, there were three customers within the U.S. segment. Two of these customers, which are large pharmaceutical distributors, accounted for 69% and 73% of the Company’s consolidated revenues for the years ended December 31, 2018 and 2017, respectively. These same two customers within the U.S. segment accounted for approximately 73% and 81% of the Company’s consolidated accounts receivable at December 31, 2018 and 2017, respectively. The Company’s chief operating decision maker is the Chief Executive Officer (CEO). While the CEO is apprised of a variety of financial metrics and information, the business is principally managed and organized based upon geographic and regulatory environment. Each segment is separately managed and is evaluated primarily upon segment income or loss from operations. Non-cash items, including stock-based compensation expense and depreciation and amortization, are categorized as Other within the tables below. The following table presents a summary of the Company ’ s reporting segments for the years ended December 31, 2018 and 2017: Year Ended U.S. International Other Consolidated (In thousands) NET REVENUE $ 32,337 $ 14,633 $ — $ 46,970 COST OF GOODS SOLD, EXCLUDING DEPRECIATION AND AMORTIZATION (3,246 ) (1,433 ) — (4,679 ) GROSS PROFIT 29,091 13,200 — 42,291 RESEARCH, DEVELOPMENT AND MEDICAL AFFAIRS EXPENSES 6,457 3,946 871 11,274 GENERAL AND ADMINISTRATIVE EXPENSES 8,147 3,259 3,119 14,525 SALES AND MARKETING EXPENSES 16,569 5,910 1,038 23,517 DEPRECIATION AND AMORTIZATION — — 2,645 2,645 OPERATING EXPENSES 31,173 13,115 7,673 51,961 SEGMENT LOSS FROM OPERATIONS (2,082 ) 85 (7,673 ) (9,670 ) OTHER INCOME AND EXPENSES, NET (6,606 ) (6,606 ) NET LOSS BEFORE TAXES $ (16,276 ) Year Ended U.S. International Other Consolidated (In thousands) NET REVENUE $ 26,146 $ 9,766 $ — $ 35,912 COST OF GOODS SOLD, EXCLUDING DEPRECIATION AND AMORTIZATION (2,482 ) (956 ) — (3,438 ) GROSS PROFIT 23,664 8,810 — 32,474 RESEARCH, DEVELOPMENT AND MEDICAL AFFAIRS EXPENSES 5,780 3,314 3,750 12,844 GENERAL AND ADMINISTRATIVE EXPENSES 7,580 2,605 2,854 13,039 SALES AND MARKETING EXPENSES 16,588 5,394 1,228 23,210 DEPRECIATION AND AMORTIZATION — — 2,684 2,684 RECOVERABLE COLLABORATION COSTS — — (2,851 ) (2,851 ) OPERATING EXPENSES 29,948 11,313 7,665 48,926 SEGMENT LOSS FROM OPERATIONS (6,284 ) (2,503 ) (7,665 ) (16,452 ) OTHER INCOME AND EXPENSES, NET (5,386 ) (5,386 ) NET LOSS BEFORE TAXES $ (21,838 ) |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2018 | |
Accounting Policies [Abstract] | |
Use of Estimates in Financial Statements | Use of Estimates in Financial Statements The financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America and, as such, include amounts based on informed estimates and judgments of management. Actual results could differ from those estimates. |
Principles of Consolidation | Principles of Consolidation The consolidated financial statements include the accounts of Alimera Sciences, Inc. and its wholly-owned subsidiaries. All significant inter-company balances have been eliminated in consolidation. |
Cash, Cash Equivalents and Restricted Cash | Cash, Cash Equivalents and Restricted Cash Cash equivalents include highly liquid investments that are readily convertible into cash and have a maturity of 90 days or less when purchased. Generally, cash and cash equivalents held at financial institutions are in excess of federally insured limits. Cash and cash equivalents were $13,043,000 and $24,067,000 as of December 31, 2018 and 2017, respectively, with approximately 82.0% and 93.0% of these balances, respectively held in U.S.-based financial institutions. |
Accounts Receivable and Allowance for Doubtful Accounts | Accounts Receivable and Allowance for Doubtful Accounts Accounts receivable are generated through sales primarily to major pharmaceutical distributors, pharmacies, hospitals and wholesalers. The Company does not require collateral from its customers for accounts receivable. The carrying amount of accounts receivable is reduced by an allowance for doubtful accounts that reflects management ’ s best estimate of the amounts that will not be collected. In addition to reviewing delinquent accounts receivable, management considers many factors in estimating its general allowance, including historical data, experience, customer types, credit worthiness and economic trends. From time to time, management may adjust its assumptions for anticipated changes in any of those or other factors expected to affect collectability. A provision for doubtful accounts is charged to operations when management determines the accounts may become uncollectable. The Company writes off accounts receivable when management determines they are uncollectable and credits payments subsequently received on such receivables to bad debt expense in the period received. As of December 31, 2018 and 2017, the Company had no reserve for doubtful accounts. |
Inventory | Inventory Inventories are stated at the lower of cost or net realizable value with cost determined under the first in, first out (FIFO) method. Included in inventory costs are component parts, work-in-progress and finished goods. The Company relies on third party manufacturers for the production of all inventory and does not capitalize any internal costs. The Company periodically reviews inventories for excess, obsolete or expiring inventory and writes down obsolete or otherwise unmarketable inventory to its estimated net realizable value. |
Intangible Assets | Intangible Assets The cost of intangible assets with determinable useful lives is amortized to reflect the pattern of economic benefits consumed, which approximates a straight-line basis, over the estimated periods benefited. The Company estimated the useful life of its intangible asset at approximately thirteen years (see Note 7). |
Property and Equipment | Property and Equipment Property and equipment are stated at cost. Additions and improvements are capitalized while repairs and maintenance are expensed. Depreciation is provided on the straight-line method over the useful life of the related assets beginning when the asset is placed in service. The estimated useful lives of the individual assets are as follows: furniture, fixtures and manufacturing equipment, five years ; automobiles, three years or the related lease life; software and information technology hardware, three years ; and office equipment and leasehold improvements are amortized over the shorter of their estimated useful lives or the related lease life. |
Impairment | Impairment Property and equipment and definite lived intangible assets are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. When indicators of impairment are present, the Company evaluates the carrying amount of such assets in relation to the operating performance and future estimated undiscounted net cash flows expected to be generated by the assets. If such assets are considered to be impaired, the impairment to be recognized is measured by the amount by which the carrying amount of the assets exceeds the fair value of the assets. The assessment of the recoverability of assets will be impacted if estimated future operating cash flows are not achieved. |
Income Taxes | Income Taxes The Company provides for income taxes based on pretax income and applicable tax rates available in the various jurisdictions in which it operates. Significant judgment is required in determining the provision for income taxes and income tax assets and liabilities, including evaluating uncertainties in the application of accounting principles and complex tax laws. Deferred income taxes are recorded for the expected tax consequences of temporary differences between the bases of assets and liabilities, as well as for loss and tax credit carryforwards for financial reporting purposes and amounts recognized for income tax purposes. A valuation allowance is recorded to reduce the Company’s deferred tax assets to the amount of future tax benefit that is more likely than not to be realized. The Company recognizes the tax benefit from an uncertain tax position only if it is more likely than not that the tax position will be sustained upon examination by the taxing authorities based on the technical merits of the position. The tax benefit recognized in the consolidated financial statements for a particular tax position is based on the largest benefit that is more likely than not to be realized. The amount of unrecognized tax benefits (UTBs) is adjusted as appropriate for changes in facts and circumstances, such as significant amendments to existing tax law, new regulations or interpretations by the taxing authorities, new information obtained during a tax examination, or resolution of an examination. The Company recognizes both accrued interest and penalties, where appropriate, related to UTBs in income tax expense. |
Research and Development Costs | Research and Development Costs Research and development costs are expensed as incurred. Research and development expenses were $1,096,000 and $4,216,000 for 2018 and 2017, respectively. During 2017, the Company expensed $2,851,000 of in-process Research and Development Expense in connection with the New Collaboration Agreement (see Note 9). |
Stock-Based Compensation | Stock-Based Compensation The Company has stock-based compensation plans under which various types of equity-based awards are granted, including restricted stock units (RSUs) and stock options. The fair values of RSUs and stock option awards, which are subject only to service conditions with graded vesting, are recognized as compensation expense, generally on a straight-line basis over a service period, net of estimated forfeitures. Compensation expense is recognized for all share-based awards based on the grant date fair value in accordance with the provisions of the Financial Accounting Standards Board (FASB) Accounting Standard Codification (ASC) 718, Compensation — Stock Compensation . The fair values for the options are estimated at the dates of grant using a Black-Scholes option-pricing model. Additionally, the Company sponsors an employee stock purchase plan (ESPP) under which U.S.-based employees may elect payroll withholdings to fund purchases of the Company’s stock at a discount. The Company estimates the fair value of the option to purchase shares of the Company’s common stock using the Black-Scholes valuation model and recognizes compensation expense in accordance with the provisions of ASC 718-50, Employee Share Purchase Plans . |
Derivative Financial Instruments | Derivative Financial Instruments The Company generally does not use derivative instruments to hedge exposures to cash flow or market risks. However, certain warrants to purchase Series A Convertible Preferred Stock or common stock that did not meet the requirements for classification as equity, in accordance with the Derivatives and Hedging Topic of the ASC, were classified as liabilities. In such instances, net-cash settlement is assumed for financial reporting purposes, even when the terms of the underlying contracts do not provide for a net-cash settlement. These warrants were considered derivative instruments at issuance because the warrant agreements (a) provided for settlement in Series A Convertible Preferred Shares or common shares at the option of the holder; (b) provided for future adjustment to the warrant exercise price for common shares; and (c) contained anti-dilution provisions whereby the number of shares for which the warrants were exercisable and/or the exercise price of the warrants were subject to change in the event of certain issuances of stock at prices below the then-effective exercise price of the warrants. Because the rights to exercise these warrants expired on October 1, 2017, the warrant exercise price no longer can be adjusted. The primary underlying risk exposure pertaining to the warrants was the change in fair value of the underlying common stock. |
Fair Value of Financial Instruments | Fair Value of Financial Instruments The carrying amounts of the Company’s financial instruments, including cash and cash equivalents and current assets and liabilities approximate their fair value because of their short maturities. The weighted average interest rate of the Company’s notes payable approximates the rate at which the Company could obtain alternative financing; therefore, the carrying amount of the note approximates the fair value. The Company uses the Black-Scholes option pricing model and assumptions that consider, among other variables, the fair value of the underlying stock, risk-free interest rate, volatility, expected life and dividend rates in estimating fair value for the warrants considered to be derivative instruments. |
Translation Policy | Foreign Currency Translation The net assets of international subsidiaries where the local currencies have been determined to be the functional currencies are translated into U.S. dollars using applicable exchange rates. The U.S. dollar effects that arise from translating net assets of these subsidiaries at changing rates are recognized in a ccumulated other comprehensive loss and is the only adjustment recognized in a ccumulated other comprehensive loss . The earnings of these subsidiaries are translated into U.S. dollars using average exchange rates. |
Earnings Per Share (EPS) | Earnings Per Share (EPS) The Company follows ASC 260, Earnings Per Share (ASC 260), which requires the reporting of both basic and diluted earnings per share. Because the Company’s preferred stockholders participate in dividends equally with common stockholders (if the Company were to declare and pay dividends), the Company uses the two-class method to calculate EPS. Basic EPS is computed by dividing net income (loss) available to stockholders by the weighted average number shares outstanding for the period. Diluted EPS is calculated in accordance with ASC 260 by adjusting weighted average shares outstanding for the dilutive effect of common stock options, restricted stock units and warrants. The Company had net income available to stockholders for 2018 due to the gain on extinguishment of preferred stock (Note 12). Basic and diluted earnings per share attributable to common and participating shares of common stock for 2018 and 2017 were as follows: Years Ended December 31, 2018 2017 (In thousands, except share and per share data) Net income (loss) available to stockholders $ 21,948 $ (22,001 ) Allocation of undistributed earnings (loss): Earnings (loss) attributable to common stock $ 17,459 $ (22,001 ) Earnings attributable to participating securities $ 4,489 $ — Basic shares: Weighted average common shares 70,002,901 66,993,649 Weighted average participating shares 17,999,307 — Total basic weighted average shares 88,002,208 66,993,649 Diluted shares: Weighted average common shares 70,002,901 66,993,649 Dilutive weighted average shares 735,580 — Total dilutive weighted common shares 70,738,481 66,993,649 Weighted average participating shares 17,999,307 — Total dilutive weighted average shares 88,737,788 66,993,649 Basic EPS $ 0.25 $ (0.33 ) Diluted EPS $ 0.25 $ (0.33 ) Common stock equivalent securities that would potentially dilute basic EPS in the future, but were not included in the computation of diluted EPS because they were either classified as participating or would have been anti-dilutive, were as follows: Years Ended December 31, 2018 2017 Series A convertible preferred stock — 9,022,556 Series B convertible preferred stock — 8,416,251 Common stock warrants 1,795,663 1,795,663 Stock options 12,447,355 11,595,510 Restricted stock units — 839,285 Total 14,243,018 31,669,265 |
Reporting Segments | Reporting Segments The Company determines segments in accordance with its internal operating structure. The Company’s chief operating decision maker is the Chief Executive Officer (CEO). While the CEO is apprised of a variety of financial metrics and information, the business is principally managed and organized based upon geographic and regulatory environment. Each segment is separately managed and is evaluated primarily on net loss from operations adjusted for certain non-cash items, such as stock-based compensation expense and depreciation and amortization. The Company does not report balance sheet information by segment because it is not reviewed by the Company’s chief operating decision maker. The Company has three reportable segments, U.S., International and Other. |
Adoption of New Accounting Standards and Accounting Standards Issued but Not Yet Adopted | Adoption of New Accounting Standards In May 2014, the Financial Accounting Standards Board (FASB) issued Accounting Standards Update (ASU) 2014-09, Revenue from Contracts with Customers (Topic 606) , which amends the guidance for the recognition of revenue from contracts with customers to transfer goods and services. The FASB subsequently issued an additional, clarifying ASU to address issues arising from implementation of the new revenue recognition standard, which became effective for interim and annual periods beginning on January 1, 2018. The new standard was required to be adopted using either a full-retrospective or a modified-retrospective approach. The Company adopted the new revenue guidance on January 1, 2018 using the modified-retrospective approach. The Company elected the practical expedient to apply the new revenue standard only to contracts that were not completed as of January 1, 2018. Adoption did not have a material impact on the Company’s financial statements on an ongoing basis. See Note 3 for additional information regarding the Company’s revenues and how the company accounts for revenue. In August 2016, the FASB issued ASU 2016-15, Classification of Certain Cash Receipts and Cash Payments (Topic 230) . ASU 2016-15 is intended to add or clarify guidance on the classification of certain cash receipts and payments in the statement of cash flows and to eliminate the diversity in practice related to such classifications. The standard is effective for annual reporting periods beginning after December 15, 2017, with early adoption permitted. The Company adopted this standard effective January 1, 2018, and the adoption of this guidance did not have a material impact on the Company’s financial statements. In November 2016, the FASB issued ASU 2016-18, Statement of Cash Flows (Topic 230) - Restricted Cash . ASU 2016-18 requires a statement of cash flows to explain the change during the period in the total of cash, cash equivalents and amounts generally described as restricted cash or restricted cash equivalents. Amounts generally described as restricted cash and restricted cash equivalents should be included with cash and cash equivalents when reconciling the beginning-of-period and end-of-period total amounts shown on the statement of cash flows. The standard is effective for interim and annual reporting periods beginning after December 15, 2017, with early adoption permitted. The Company adopted this standard effective January 1, 2018, and the adoption of this guidance did not have a material impact on the Company’s financial statements. The Company’s condensed consolidated statement of cash flows for the year ended December 31, 2017 has been reclassified for this ASU. In May 2017, the FASB issued ASU No. 2017-09, Compensation - Stock Compensation (Topic 718): Scope Modification Accounting . The new standard clarifies when changes to the terms or conditions of a share-based payment award must be accounted for as modifications. This standard became effective on January 1, 2018, and the Company adopted it on that date. The adoption of this guidance did not have a material impact on the Company’s financial statements. Accounting Standards Issued but Not Yet Effective In February 2016, the FASB issued ASU 2016-02, Leases (ASC 842) , to increase transparency and comparability among organizations for lease recognition and disclosure. ASU 2016-02 requires lessees to recognize lease assets and lease liabilities on the balance sheet, while recognizing expenses on the income statements in a manner similar to current guidance. ASU 2016-02 is effective for fiscal years beginning after December 15, 2018, including interim periods within those fiscal years, with early adoption permitted. The Company did not early adopt this standard and therefore the standard will be effective for the Company in the first quarter of 2019. ASU 2016-02 requires that leases be recognized and measured as of the earliest period presented, using a modified retrospective approach, with all periods presented being adjusted and presented under the new standard. In July 2018, the FASB issued ASU 2018-11, Leases (ASC 842) : Targeted Improvements, which provides companies an optional adoption method to ASU 2016-02 whereby a company does not have to adjust comparative period financial statements for the new standard. The Company will adopt this ASU on January 1, 2019 and will not restate comparative periods. The Company is substantially complete with its implementation plan. The Company plans to elect the transition package of three practical expedients permitted within the standard. In accordance with the package of practical expedients, the Company will not reassess initial direct costs, lease classification, or whether its contracts contain or are leases. The Company also made an accounting policy election to not recognize right-of-use assets and liabilities for leases with a term of 12 months or less, unless the leases include options to renew or purchase the underlying asset that are reasonably certain to be exercised. Based on the Company’s lease portfolio as of December 31, 2018, the Company plans to recognize an operating lease liability and related right-of-use asset on our balance sheet of approximately $1,250,000 , which represents the present value of our future minimum lease payments related to operating leases, primarily related to leases of real estate. The Company expects the deferred tax impacts of the adjustment to be nominal. In February 2018, the FASB issued ASU 2018-02, Reclassification of Certain Tax Effects from Accumulated Other Comprehensive Income , to allow reclassification from accumulated other comprehensive income to retained earnings for stranded tax effects resulting from the Tax Cuts and Jobs Act. Upon adoption of the ASU, entities will be required to describe the accounting policy for releasing income tax effects from accumulated other comprehensive income. The standard is required to be adopted for periods beginning after December 15, 2018, with early adoption available. The Company will adopt this standard effective January 1, 2019, and the Company does not believe the adoption of this standard will have a material impact on the Company’s financial statements. In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments - Credit losses (Topic 326): Measurement of Credit Losses on Financial Instruments . This ASU replaces the current incurred loss impairment methodology for financial assets measured at amortized cost with a methodology that reflects expected credit losses and requires consideration of a broader range of reasonable and supportable information, including forecasted information, to develop credit loss estimates. The standard is effective for annual periods beginning after December 15, 2019, including interim periods within those annual periods, with early adoption available. The Company has implemented process controls and systems to ensure compliance with this standard. The Company is in the process of determining the effect that the adoption will have on its financial statements. In June 2018, the FASB issued ASU No. 2018-07, Stock-based Compensation: Improvements to Nonemployee Share-based Payment Accounting , which amends the existing accounting standards for share-based payments to nonemployees. This ASU aligns much of the guidance on measuring and classifying nonemployee awards with that of awards to employees. Under the new guidance, the measurement of nonemployee equity awards is fixed on the grant date. Entities will apply the ASU by recognizing a cumulative-effect adjustment to retained earnings as of the beginning of the annual period of adoption. The Company will adopt this standard effective January 1, 2019, and the Company does not believe the adoption of this standard will have a material impact on the Company’s financial statements. |
Revenue Recognition | REVENUE RECOGNITION Net Revenue The Company sells its products to major pharmaceutical distributors, pharmacies, hospitals and wholesalers (collectively, its Customers). In addition to distribution agreements with Customers, the Company enters into arrangements with healthcare providers and payors that provide for government-mandated and/or privately-negotiated rebates, chargebacks, and discounts with respect to the purchase of the Company’s products. All of the Company’s current contracts have a single performance obligation, as the promise to transfer the individual goods is not separately identifiable from other promises in the contracts and is, therefore, not distinct. Currently, all of the Company’s revenue is derived from product sales. The Company recognizes revenues from product sales at a point in time when the Customer obtains control, typically upon delivery. The Company accrues for fulfillment costs when the related revenue is recognized. Taxes collected from Customers relating to product sales and remitted to governmental authorities are excluded from revenues. As of December 31, 2018 and 2017, the Company had received a total of $1,000,000 and $500,000 , respectively, of payments that it has not recognized as revenue based on the Company’s analysis in connection with Topic 606. These deferred revenues are included as a component of other non-current liabilities on the Company’s balance sheets. Estimates of Variable Consideration Revenues from product sales are recorded at the net sales price (transaction price), which includes estimates of variable consideration for reserves related to statutory rebates to State Medicaid and other government agencies; commercial rebates and fees to Managed Care Organizations (MCOs), Group Purchasing Organizations (GPOs), distributors, and specialty pharmacies; product returns; sales discounts (including trade discounts); distributor costs; wholesaler chargebacks; and allowances for patient assistance programs relating to the Company’s sales of its products. These reserves are based on estimates of the amounts earned or to be claimed on the related sales. Management’s estimates take into consideration historical experience, current contractual and statutory requirements, specific known market events and trends, industry data, and Customer buying and payment patterns. Overall, these reserves reflect the Company’s best estimates of the amount of consideration to which it is entitled based on the terms of the contract. The amount of variable consideration included in the net sales price is limited to the amount that is probable not to result in a significant reversal in the amount of the cumulative revenue recognized in a future period. If actual results vary, the Company may adjust these estimates, which could have an effect on earnings in the period of adjustment. Consideration Payable to Customers Distribution service fees are payments issued to distributors for compliance with various contractually-defined inventory management practices or services provided to support patient access to a product. Distribution service fees reserves are based on the terms of each individual contract and are classified within accrued expenses and are recorded as a reduction of revenue. Product Returns The Company’s policies provide for product returns in the following circumstances: (a) expiration of shelf life on certain products; (b) product damaged while in the Customer’s possession; and (c) following product recalls. Generally, returns for expired product are accepted three months before and up to one year after the expiration date of the related product, and the related product is destroyed after it is returned. The Company may either refund the sales price paid by the Customer by issuance of a credit, or exchange the returned product with replacement inventory. The Company typically does not provide cash refunds. The Company estimates the proportion of recorded revenue that will result in a return by considering relevant factors, including historical returns experience, the estimated level of inventory in the distribution channel, the shelf life of products and product recalls, if any. The estimation process for product returns involves, in each case, a number of interrelating assumptions, which vary for each Customer. The Company estimates the amount of its product sales that may be returned by its Customers and records this estimate as a reduction of revenue from product sales in the period the related revenue is recognized, and because this returned product cannot be resold, there is no corresponding asset for product returns. To date, product returns have been minimal. Other Revenue The Company enters into agreements in which it licenses certain rights to its products to partner companies that act as distributors. The terms of these arrangements may include payment to the Company of one or more of the following: non-refundable, up-front license fees; development, regulatory and commercial milestone payments; payments for manufacturing supply services the Company provides; and a revenue share on net sales of licensed products. Each of these payments is recognized as other revenues. As part of the accounting for these arrangements, the Company must develop estimates that require judgment to determine the stand-alone selling price for each performance obligation identified in the contract. Performance obligations are promises in a contract to transfer a distinct good or service to the Customer, and the Company recognizes revenue when, or as, performance obligations are satisfied. The Company uses key assumptions to determine the stand-alone selling price; these assumptions may include forecasted revenues, development timelines, reimbursement rates for personnel costs, discount rates and probabilities of technical, regulatory and commercial success. Certain of these agreements include consideration in the form of milestone payments. At the inception of each arrangement that includes milestone payments, the Company evaluates the recognition of milestone payments. Typically, milestone payments are associated with events that are not entirely within the control of the Company or the licensee, such as regulatory approvals; are included in the transaction price; and are subject to a constraint until it is probable that there will not be a significant revenue reversal, typically upon achievement of the milestone. At the end of each reporting period, the Company re-evaluates the probability of achievement of such milestones and any related constraint, and if necessary, adjusts its estimate of the overall transaction price. Customer Payment Obligations The Company receives payments from its Customers based on billing schedules established in each contract, which vary across the Company’s locations, but generally range between 30 to 120 days. Occasionally, the timing of receipt of payment for the Company’s international Customers can be extended. Amounts are recorded as accounts receivable when the Company’s right to consideration is unconditional. The Company does not assess whether a contract has a significant financing component if the expectation is that the Customer will pay for the product or services in one year or less of receiving those products or services. |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Accounting Policies [Abstract] | |
Summary of Basic and Diluted Earnings Per Share Attributable to Common and Participating Shares of Common Stock | Basic and diluted earnings per share attributable to common and participating shares of common stock for 2018 and 2017 were as follows: Years Ended December 31, 2018 2017 (In thousands, except share and per share data) Net income (loss) available to stockholders $ 21,948 $ (22,001 ) Allocation of undistributed earnings (loss): Earnings (loss) attributable to common stock $ 17,459 $ (22,001 ) Earnings attributable to participating securities $ 4,489 $ — Basic shares: Weighted average common shares 70,002,901 66,993,649 Weighted average participating shares 17,999,307 — Total basic weighted average shares 88,002,208 66,993,649 Diluted shares: Weighted average common shares 70,002,901 66,993,649 Dilutive weighted average shares 735,580 — Total dilutive weighted common shares 70,738,481 66,993,649 Weighted average participating shares 17,999,307 — Total dilutive weighted average shares 88,737,788 66,993,649 Basic EPS $ 0.25 $ (0.33 ) Diluted EPS $ 0.25 $ (0.33 ) |
Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share | Common stock equivalent securities that would potentially dilute basic EPS in the future, but were not included in the computation of diluted EPS because they were either classified as participating or would have been anti-dilutive, were as follows: Years Ended December 31, 2018 2017 Series A convertible preferred stock — 9,022,556 Series B convertible preferred stock — 8,416,251 Common stock warrants 1,795,663 1,795,663 Stock options 12,447,355 11,595,510 Restricted stock units — 839,285 Total 14,243,018 31,669,265 |
Inventory (Tables)
Inventory (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Inventory Disclosure [Abstract] | |
Schedule of Inventory | Inventory consisted of the following: December 31, 2018 2017 (In thousands) Component parts (1) $ 129 $ 404 Work-in-process (2) 924 587 Finished goods 1,352 517 Total inventory 2,405 1,508 (1) Component parts inventory consisted of manufactured components of the ILUVIEN applicator. (2) Work-in-process consisted of completed units of ILUVIEN that are undergoing, but have not completed, quality assurance testing as required by U.S. or EEA regulatory authorities. |
Property and Equipment (Tables)
Property and Equipment (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Property, Plant and Equipment [Abstract] | |
Schedule of Property and Equipment | Property and equipment consisted of the following: December 31, 2018 2017 (In thousands) Furniture and fixtures $ 392 $ 392 Office equipment 869 864 Automobiles 870 663 Software 1,275 1,122 Leasehold improvements 474 482 Manufacturing equipment 1,087 1,088 Total property and equipment 4,967 4,611 Less accumulated depreciation and amortization (3,612 ) (3,201 ) Property and equipment — net $ 1,355 $ 1,410 |
Intangible Assets (Tables)
Intangible Assets (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Schedule of Intangible Assets Future Amortization Expense | The estimated remaining amortization as of December 31, 2018 is as follows (in thousands): Years Ending December 31 2019 $ 1,940 2020 1,946 2021 1,940 2022 1,940 2023 1,940 Thereafter 7,017 Total $ 16,723 |
Accrued Expenses (Tables)
Accrued Expenses (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Payables and Accruals [Abstract] | |
Summary of Accrued Expenses | Accrued expenses consisted of the following: December 31, 2018 2017 (In thousands) Accrued clinical investigator expenses $ 781 $ 696 Accrued compensation expenses 1,427 511 Accrued rebate, chargeback and other revenue reserves 346 305 Accrued End of Term Payment (see Note 10) — 1,400 Other accrued expenses 1,089 670 Total accrued expenses $ 3,643 $ 3,582 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Commitments and Contingencies Disclosure [Abstract] | |
Schedule of Future Minimum Principal Payments Under Note Payable | Under the 2018 Loan Agreement with Solar Capital (see Note 10), as of December 31, 2018 , the Company was obligated to make future minimum principal payments, excluding the $1,800,000 fee that will be due upon repayment of the term loan in full, as follows: Years Ending December 31 (In thousands) 2019 $ — 2020 8,333 2021 20,000 2022 11,667 Total 40,000 Less unamortized repayment fee (1,296 ) Less unamortized deferred financing costs (831 ) Less current portion — Non-current portion $ 37,873 |
Schedule of Future Minimum Rental Payments for Operating Leases | As of December 31, 2018 , a schedule by year of future minimum payments under all of the Company’s operating leases is as follows: Years Ending December 31 (In thousands) 2019 $ 564 2020 421 2021 300 Total $ 1,285 |
Schedule by Year of Future Minimum Payments under Capital Leases, Together with Present Value of Minimum Lease Payments | As of December 31, 2018 , a schedule by year of future minimum payments under capital leases, together with the present value of minimum lease payments, is as follows (in thousands): Years Ending December 31 (In thousands) 2019 $ 328 2020 297 2021 76 Total 701 Less amount representing interest (42 ) Less amount representing executory costs (118 ) Present value of minimum lease payments 541 Less current portion (236 ) Non-current portion $ 305 |
Schedule of Property and Equipment Under Capital Leases | Property and equipment under capital leases, which are included in property and equipment (Note 6), consisted of the following: December 31, 2018 2017 (In thousands) Automobiles $ 870 $ 663 Office equipment 60 63 Less accumulated depreciation (315 ) (311 ) Total $ 615 $ 415 |
Stock Incentive Plans (Tables)
Stock Incentive Plans (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Summary of Stock Option Transactions | A summary of stock option transactions under the plans are as follows: Years Ended December 31, 2018 2017 Options Weighted Average Exercise Price Options Weighted Average Exercise Price Options outstanding at beginning of period 11,595,510 $ 2.90 10,804,412 $ 3.22 Grants 2,111,375 1.07 2,336,300 1.25 Forfeitures (1,257,967 ) 2.54 (1,544,473 ) 2.63 Exercises (1,563 ) 1.06 (729 ) 1.49 Options outstanding at year end 12,447,355 2.63 11,595,510 2.90 Options exercisable at year end 9,138,544 3.09 8,085,064 3.25 Weighted average per share fair value of options granted during the year $ 0.71 $ 0.94 |
Summary of Additional Stock Option Transactions | The following table provides additional information related to outstanding stock options, fully vested stock options, and stock options expected to vest as of December 31, 2018 : Shares Weighted Average Exercise Price Weighted Average Contractual Term Aggregate Intrinsic Value (In thousands) Outstanding 12,447,355 $ 2.63 6.25 years $ — Exercisable 9,138,544 3.09 5.37 years — Outstanding, vested and expected to vest 12,044,311 2.67 6.16 years — |
Weighted-Average Assumptions Used for Option Grants | The weighted-average assumptions used for option grants were as follows: Years Ended December 31, 2018 2017 Risk-free interest rate 2.63 % 2.06 % Volatility factor 72.60 % 90.49 % Grant date fair value of common stock options $ 0.71 $ 0.94 Weighted-average expected life 6.02 years 6.02 years Assumed forfeiture rate 10.00 % 10.00 % |
Employee Stock-Based Compensation Expense | Employee stock-based compensation expense related to stock options recognized in accordance with ASC 718 was as follows: Years Ended December 31, 2018 2017 (In thousands) Sales and marketing $ 685 $ 907 Research, development and medical affairs 565 643 General and administrative 2,130 2,510 Total employee stock-based compensation expense related to stock options $ 3,380 $ 4,060 |
Summary of Restricted Stock Unit Transactions | A summary of RSU transactions under the plans are as follows: Years Ended December 31, 2018 2017 RSUs Weighted Average Grant Date Fair Value RSUs Weighted Average Grant Date Fair Value Restricted stock units outstanding at beginning of period 839,285 $ 1.21 — $ — Grants 1,091,712 1.15 964,720 1.21 Vested units (839,285 ) 1.21 — — Forfeitures (191,460 ) 1.15 (125,435 ) 1.18 Restricted stock units outstanding at year end 900,252 1.15 839,285 1.21 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Income Tax Disclosure [Abstract] | |
Components of Net Loss before Taxes | The components of net loss before taxes are as follows: Years Ended December 31, 2018 2017 (In thousands) United States $ (2,908 ) $ (1,890 ) Foreign (13,368 ) (19,948 ) Loss before provision for income taxes $ (16,276 ) $ (21,838 ) |
Components of Income Tax Benefit | The provision for income taxes consists of the following components: Years Ended December 31, 2018 2017 (In thousands) Current expense (benefit): Federal $ — $ — State — — Foreign 759 255 Current income tax expense 759 255 Deferred expense (benefit): Federal 256 549 State 411 3,330 Foreign (654 ) (92 ) 13 3,787 Valuation allowance (666 ) (3,879 ) Deferred income tax benefit (653 ) (92 ) Total income tax expense $ 106 $ 163 |
Summary of Valuation Allowance | The following summarizes activity related to the Company ’ s valuation allowance: Years Ended December 31, 2018 2017 (In thousands) Valuation allowance at beginning of period $ (41,485 ) $ (55,968 ) Income tax provision (666 ) (3,879 ) U.S. Tax Reform — 18,362 Valuation allowance at end of period $ (42,151 ) $ (41,485 ) |
Net Deferred Tax Assets (Liabilities) | Worldwide net deferred tax assets and liabilities are as follows: December 31, 2018 2017 Deferred tax assets (In thousands) Depreciation and amortization $ 55 $ 44 Other deferred tax assets 1,382 707 NOL carry-forwards 34,217 33,980 Research and development costs 813 1,340 Equity compensation 4,485 3,686 Collaboration agreement receivable reserves 2,381 2,256 Valuation allowance (42,151 ) (41,485 ) Total deferred tax assets $ 1,182 $ 528 |
Reconciliation of Income Tax Benefit to Amount Determined by Applying U.S. Federal Statutory Income Tax Rate | A reconciliation from the federal statutory rate to the total provision for income taxes is as follows: Years Ended December 31, 2018 2017 Amount Percent Amount Percent (in thousands, except percentages) Federal tax benefit at statutory rate $ (3,463 ) 21.0 % $ (7,425 ) 34.0 % State tax — net of federal benefit 1 — (3,783 ) 17.3 Permanent items and other 528 (3.2 ) 686 (3.1 ) Foreign rate differential 2,946 (17.9 ) 6,880 (31.5 ) U.S. tax reform — — 18,362 (84.1 ) Deferred rate change (438 ) 2.7 (212 ) 1.0 Other (134 ) 0.8 138 (0.6 ) Change in valuation allowance 666 (4.0 ) (14,483 ) 66.3 Total tax expense (benefit) $ 106 (0.6 )% $ 163 (0.7 )% |
Uncertain Tax Positions Rollforward | A rollforward of the Company’s uncertain tax positions is as follows: Years Ended December 31, 2018 2017 (In thousands) Balance of uncertain tax positions at beginning of period $ 52 $ 59 Gross increases - tax positions in current period 13 4 Gross increases - tax positions in prior period 10 — Gross decreases - tax positions in prior period (7 ) (11 ) Settlements — — Lapse of statute of limitations — — Balance of uncertain tax positions at end of period $ 68 $ 52 |
Segment Information (Tables)
Segment Information (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Segment Reporting [Abstract] | |
Schedule of Reporting Segments | The following table presents a summary of the Company ’ s reporting segments for the years ended December 31, 2018 and 2017: Year Ended U.S. International Other Consolidated (In thousands) NET REVENUE $ 32,337 $ 14,633 $ — $ 46,970 COST OF GOODS SOLD, EXCLUDING DEPRECIATION AND AMORTIZATION (3,246 ) (1,433 ) — (4,679 ) GROSS PROFIT 29,091 13,200 — 42,291 RESEARCH, DEVELOPMENT AND MEDICAL AFFAIRS EXPENSES 6,457 3,946 871 11,274 GENERAL AND ADMINISTRATIVE EXPENSES 8,147 3,259 3,119 14,525 SALES AND MARKETING EXPENSES 16,569 5,910 1,038 23,517 DEPRECIATION AND AMORTIZATION — — 2,645 2,645 OPERATING EXPENSES 31,173 13,115 7,673 51,961 SEGMENT LOSS FROM OPERATIONS (2,082 ) 85 (7,673 ) (9,670 ) OTHER INCOME AND EXPENSES, NET (6,606 ) (6,606 ) NET LOSS BEFORE TAXES $ (16,276 ) Year Ended U.S. International Other Consolidated (In thousands) NET REVENUE $ 26,146 $ 9,766 $ — $ 35,912 COST OF GOODS SOLD, EXCLUDING DEPRECIATION AND AMORTIZATION (2,482 ) (956 ) — (3,438 ) GROSS PROFIT 23,664 8,810 — 32,474 RESEARCH, DEVELOPMENT AND MEDICAL AFFAIRS EXPENSES 5,780 3,314 3,750 12,844 GENERAL AND ADMINISTRATIVE EXPENSES 7,580 2,605 2,854 13,039 SALES AND MARKETING EXPENSES 16,588 5,394 1,228 23,210 DEPRECIATION AND AMORTIZATION — — 2,684 2,684 RECOVERABLE COLLABORATION COSTS — — (2,851 ) (2,851 ) OPERATING EXPENSES 29,948 11,313 7,665 48,926 SEGMENT LOSS FROM OPERATIONS (6,284 ) (2,503 ) (7,665 ) (16,452 ) OTHER INCOME AND EXPENSES, NET (5,386 ) (5,386 ) NET LOSS BEFORE TAXES $ (21,838 ) |
Nature of Operations (Detail)
Nature of Operations (Detail) - ILUVIEN | 1 Months Ended | 12 Months Ended |
Dec. 31, 2017country | Dec. 31, 2018Patient | |
Nature Of Operations [Line Items] | ||
Post-authorization open study period | 5 years | |
Maximum number of patients involved in post-authorization open study period | 800 | |
Number of patients involved in post-authorization open study period | 562 | |
Number of countries in which company plans to file application for new indication | country | 17 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - Additional Information (Detail) | 12 Months Ended | ||
Dec. 31, 2018USD ($)Segment | Dec. 31, 2017USD ($) | Jan. 01, 2019USD ($) | |
Accounting Policies [Abstract] | |||
Cash and cash equivalents | $ 13,043,000 | $ 24,067,000 | |
Percentage of cash and cash equivalents in domestic financial institutions | 82.00% | 93.00% | |
Reserve for doubtful accounts | $ 0 | $ 0 | |
Useful life of intangible assets | 13 years | ||
Research and development expense | $ 1,096,000 | 4,216,000 | |
In-process research and development expense | $ 2,851,000 | ||
Number of reportable segments | Segment | 3 | ||
Scenario, Forecast | Accounting Standards Update 2016-02 | |||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |||
Operating lease, liability | $ 1,250,000 | ||
Operating lease, right-of-use asset | $ 1,250,000 |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - Property and Equipment (Details) | 12 Months Ended |
Dec. 31, 2018 | |
Furniture and fixtures | |
Property, Plant and Equipment [Line Items] | |
Estimated useful lives | 5 years |
Automobiles | |
Property, Plant and Equipment [Line Items] | |
Estimated useful lives | 3 years |
Software | |
Property, Plant and Equipment [Line Items] | |
Estimated useful lives | 3 years |
Summary of Significant Accoun_6
Summary of Significant Accounting Policies - Summary of Basic and Diluted Earnings Per Share Attributable to Common and Participating Shares of Common Stock (Details) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Accounting Policies [Abstract] | ||
NET INCOME (LOSS) AVAILABLE TO STOCKHOLDERS | $ 21,948 | $ (22,001) |
Allocation of undistributed earnings (loss): | ||
Earnings (loss) attributable to common stock | 17,459 | (22,001) |
Earnings attributable to participating securities | $ 4,489 | $ 0 |
Basic shares: | ||
Weighted average common shares (in shares) | 70,002,901 | 66,993,649 |
Weighted average participating shares (in shares) | 17,999,307 | 0 |
Total basic weighted average shares (in shares) | 88,002,208 | 66,993,649 |
Diluted shares: | ||
Dilutive weighted average shares (in shares) | 735,580 | 0 |
Total dilutive weighted common shares (in shares) | 70,738,481 | 66,993,649 |
Weighted average participating shares (in shares) | 17,999,307 | 0 |
Total dilutive weighted average shares (in shares) | 88,737,788 | 66,993,649 |
Basic EPS (USD per share) | $ 0.25 | $ (0.33) |
Diluted EPS (USD per share) | $ 0.25 | $ (0.33) |
Summary of Significant Accoun_7
Summary of Significant Accounting Policies - Securities Not Included in Computation of Diluted EPS (Detail) - shares | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total potentially dilutive securities (in shares) | 14,243,018 | 31,669,265 |
Series A convertible preferred stock | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total potentially dilutive securities (in shares) | 0 | 9,022,556 |
Series B convertible preferred stock | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total potentially dilutive securities (in shares) | 0 | 8,416,251 |
Common stock warrants | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total potentially dilutive securities (in shares) | 1,795,663 | 1,795,663 |
Stock options | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total potentially dilutive securities (in shares) | 12,447,355 | 11,595,510 |
Restricted stock units | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total potentially dilutive securities (in shares) | 0 | 839,285 |
Revenue Recognition - Narrative
Revenue Recognition - Narrative (Details) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Revenue from Contract with Customer [Abstract] | ||
Milestone payments not recognized as revenue | $ 1,000 | $ 500 |
Going Concern (Detail)
Going Concern (Detail) - USD ($) | Dec. 31, 2018 | Jan. 05, 2018 | Dec. 31, 2017 |
Line of Credit Facility [Line Items] | |||
Accumulated deficit | $ (377,127,000) | $ (399,075,000) | |
Cash and cash equivalents | $ 13,043,000 | $ 24,067,000 | |
Solar Capital Ltd. | 2018 Loan Agreement | |||
Line of Credit Facility [Line Items] | |||
Line of credit maximum borrowing capacity | $ 40,000,000 |
Inventory (Detail)
Inventory (Detail) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Inventory net realizable value | ||
Component parts | $ 129 | $ 404 |
Work-in-process | 924 | 587 |
Finished goods | 1,352 | 517 |
Total inventory | $ 2,405 | $ 1,508 |
Property and Equipment (Detail)
Property and Equipment (Detail) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Property, Plant and Equipment [Line Items] | ||
Total property and equipment | $ 4,967 | $ 4,611 |
Less accumulated depreciation and amortization | (3,612) | (3,201) |
Property and equipment — net | 1,355 | 1,410 |
Depreciation expense | 705 | 744 |
Furniture and fixtures | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment | 392 | 392 |
Office equipment | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment | 869 | 864 |
Automobiles | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment | 870 | 663 |
Software | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment | 1,275 | 1,122 |
Leasehold improvements | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment | 474 | 482 |
Manufacturing equipment | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment | $ 1,087 | $ 1,088 |
Intangible Assets - Narrative (
Intangible Assets - Narrative (Details) - USD ($) | 1 Months Ended | 12 Months Ended | |
Oct. 31, 2014 | Dec. 31, 2018 | Dec. 31, 2017 | |
Finite-Lived Intangible Assets [Line Items] | |||
Useful life | 13 years | ||
Intangible assets, net | $ 16,723,000 | ||
Licensing Agreement | |||
Finite-Lived Intangible Assets [Line Items] | |||
Intangible assets, gross | $ 25,000,000 | ||
Useful life | 13 years | ||
Intangible assets, net | $ 16,723,000 | $ 18,664,000 | |
Intangible asset amortization expense | $ 1,940,000 | ||
Collaborative Arrangement, Co-promotion | |||
Finite-Lived Intangible Assets [Line Items] | |||
Additional milestone payment after the first product approved by the FDA | $ 25,000,000 |
Intangible Assets - Future Amor
Intangible Assets - Future Amortization Expense (Details) $ in Thousands | Dec. 31, 2018USD ($) |
Finite-Lived Intangible Assets, Net, Amortization Expense, Fiscal Year Maturity [Abstract] | |
2,019 | $ 1,940 |
2,020 | 1,946 |
2,021 | 1,940 |
2,022 | 1,940 |
2,023 | 1,940 |
Thereafter | 7,017 |
Total | $ 16,723 |
Accrued Expenses (Detail)
Accrued Expenses (Detail) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Payables and Accruals [Abstract] | ||
Accrued clinical investigator expenses | $ 781 | $ 696 |
Accrued compensation expenses | 1,427 | 511 |
Accrued rebate, chargeback and other revenue reserves | 346 | 305 |
Accrued End of Term Payment (see Note 10) | 0 | 1,400 |
Other accrued expenses | 1,089 | 670 |
Total accrued expenses | $ 3,643 | $ 3,582 |
License Agreements (Details)
License Agreements (Details) - USD ($) | Jul. 10, 2017 | Sep. 30, 2018 | Dec. 31, 2018 | Dec. 31, 2017 | Jun. 30, 2017 |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||
In-process research and development expense | $ 2,851,000 | ||||
Collaborative Arrangement, Co-promotion | |||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||
Share of net profits | 20.00% | 20.00% | |||
Share of any lump sum milestone payments received from sub licensee | 33.00% | ||||
Recovery of commercialization costs | 20.00% | ||||
Collaborative arrangement, royalty payable on net revenue (as a percentage) | 2.00% | ||||
Collaborative arrangement, increase in royalty payable on net revenue (as a percentage) | 6.00% | ||||
Collaborative arrangement, royalty payable on net revenue over threshold (as a percentage) | 2.00% | ||||
Collaborative arrangement, royalty payable on net revenue, revenue threshold | $ 75,000,000 | ||||
Royalty expense | $ 998,000 | $ 621,000 | |||
Collaborative arrangement, forgiveness of future offset | 10,000,000 | ||||
Collaborative agreement, capped future offset amount | $ 25,000,000 | ||||
Reduction in royalty on net revenues up to threshold, first two years (as a percentage) | 4.00% | ||||
Reduction in royalty on net revenues in excess of threshold, first two years (as a percentage) | 5.00% | ||||
Reduction in royalty on net revenues up to threshold, third year and thereafter (as a percentage) | 5.20% | ||||
Reduction in royalty on net revenues in excess of threshold, third year and thereafter (as a percentage) | 6.80% | ||||
Collaborative arrangement, forgiveness of future offset, additional amount | $ 5,000,000 | ||||
In-process research and development expense | $ 2,851,000 | ||||
Minimum days to require to revert license in case of breaches of contract | 30 days | ||||
Maximum days to require to revert license in case of breaches of contract | 90 days | ||||
Period of bankruptcy petition proceedings remains undismissed | 60 days | ||||
Collaborative Arrangement, Co-promotion | Maximum | |||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||
Recoverable amount to offset future royalty payments | 15,000,000 | ||||
Collaborative arrangement, forgiveness of future offset, additional amount | $ 5,000,000 | ||||
Collaborative Arrangement, Co-promotion | Accounts Payable | |||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||
Royalty expense | $ 428,000 | ||||
New Collaboration Agreement, 2017 Second Amended | |||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||
Royalty future offset | $ 14,937,000 | $ 25,000,000 |
Loan Agreements - Hercules Loan
Loan Agreements - Hercules Loan Agreement (Details) - Alimera Sciences Limited - Hercules Technology Growth Capital - USD ($) | Jan. 05, 2018 | Oct. 31, 2016 | Dec. 31, 2017 | Apr. 30, 2014 |
2014 Term Loan | ||||
Line of Credit Facility [Line Items] | ||||
Line of credit maximum borrowing capacity | $ 35,000,000 | |||
Interest rate on Term Loan Agreement | 12.00% | |||
Fourth Loan Amendment | ||||
Line of Credit Facility [Line Items] | ||||
Interest rate on term loan (percent) | 11.00% | |||
Payment-in-kind interest rate | 1.00% | |||
Prepayment fee percentage within the second year of borrowing | 2.00% | |||
Repayments of debt | $ 709,000 | |||
Upfront fee payment to Lenders | $ 1,400,000 | |||
Prime Rate | Fourth Loan Amendment | ||||
Line of Credit Facility [Line Items] | ||||
Basis spread on variable rate (percent) | 11.00% | |||
Reduction in basis spread on variable rate | 3.50% |
Loan Agreements - 2014 and 2016
Loan Agreements - 2014 and 2016 Warrants (Details) - Hercules Technology Growth Capital - $ / shares | Oct. 31, 2016 | Jul. 31, 2016 | Apr. 30, 2014 |
Alimera Sciences, Inc. | 2014 Term Loan | |||
Class of Warrant or Right [Line Items] | |||
Number of shares called by warrants (in shares) | 285,016 | ||
Exercise price on warrants (in dollars per share) | $ 6.14 | ||
Alimera Sciences, Inc. | July 2016 Waiver | |||
Class of Warrant or Right [Line Items] | |||
Number of shares called by warrants (in shares) | 1,258,993 | ||
Exercise price on warrants (in dollars per share) | $ 1.39 | ||
Alimera Sciences Limited | Fourth Loan Amendment | |||
Class of Warrant or Right [Line Items] | |||
Number of shares called by warrants (in shares) | 458,716 | ||
Exercise price on warrants (in dollars per share) | $ 1.09 |
Loan Agreements - Solar Capital
Loan Agreements - Solar Capital Loan Agreement (Details) - USD ($) | Jan. 05, 2018 | Dec. 31, 2018 | Dec. 31, 2017 |
Line of Credit Facility [Line Items] | |||
NET REVENUE | $ 46,970,000 | $ 35,912,000 | |
Solar Capital Ltd. | 2018 Loan Agreement | |||
Line of Credit Facility [Line Items] | |||
Line of credit maximum borrowing capacity | $ 40,000,000 | ||
Interest only payments, term (in months) | 30 months | ||
Principal and interest payments, term (in months) | 24 months | ||
Interest only payments, additional term | 6 months | ||
Principal and interest payments, adjusted term (in months) | 18 months | ||
Payments for closing fees | $ 400,000 | ||
Upfront fee payment to Lenders | 1,800,000 | ||
Fee amount if interest only period is extended | $ 2,000,000 | ||
Interest only payments, extension term (in months) | 36 months | ||
Incremental prepayments of outstanding balance | $ 10,000,000 | ||
Debt instrument, additional exit fee | $ 1,000,000 | ||
Percentage of voting interests | 65.00% | ||
LIBOR | Solar Capital Ltd. | 2018 Loan Agreement | |||
Line of Credit Facility [Line Items] | |||
Basis spread on variable rate (percent) | 7.65% | ||
Alimera Sciences Limited | Solar Capital Ltd. | 2018 Loan Agreement | |||
Line of Credit Facility [Line Items] | |||
Interest rate on term loan (percent) | 10.00% | ||
Tranche One | Solar Capital Ltd. | 2018 Loan Agreement | |||
Line of Credit Facility [Line Items] | |||
Principal prepayment fee percentage, first 12 months | 2.00% | ||
Tranche Two | Solar Capital Ltd. | 2018 Loan Agreement | |||
Line of Credit Facility [Line Items] | |||
Principal prepayment fee percentage, greater than 12 months, less than 24 months | 1.00% | ||
Tranche Three | Solar Capital Ltd. | 2018 Loan Agreement | |||
Line of Credit Facility [Line Items] | |||
Principal prepayment fee percentage, greater than 24 months | 0.50% | ||
Number of days before maturity date | 30 days | ||
Exit Fee Agreement | Solar Capital Ltd. | 2018 Loan Agreement | |||
Line of Credit Facility [Line Items] | |||
Debt instrument, term (in years) | 10 years | ||
Debt instrument, exit fee | $ 2,000,000 | ||
ILUVIEN | Tranche One | Solar Capital Ltd. | 2018 Loan Agreement | |||
Line of Credit Facility [Line Items] | |||
NET REVENUE | 80,000,000 | ||
ILUVIEN | Tranche Two | Solar Capital Ltd. | 2018 Loan Agreement | |||
Line of Credit Facility [Line Items] | |||
NET REVENUE | $ 100,000,000 |
Loan Agreements - Extinguishmen
Loan Agreements - Extinguishment of Debt (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Debt Instrument [Line Items] | ||
Loss on early extinguishment of debt | $ 1,766 | $ 0 |
Alimera Sciences Limited | Fourth Loan Amendment | Hercules Technology Growth Capital | ||
Debt Instrument [Line Items] | ||
Loss on early extinguishment of debt | $ 1,766 |
Commitments and Contingencies -
Commitments and Contingencies - Narrative (Detail) $ in Thousands | Jan. 01, 2019USD ($)Employee | Feb. 29, 2016 | May 31, 2013contract | Feb. 28, 2010 | Dec. 31, 2018USD ($)Employee | Dec. 31, 2017USD ($) | Dec. 31, 2016agreement | Jan. 05, 2018USD ($) |
Commitments and Contingencies [Line Items] | ||||||||
Accrued and unpaid interest payable on Note Payable | $ 345 | $ 363 | ||||||
Rent expense under all operating leases | 509 | 499 | ||||||
Depreciation expense | $ 705 | 744 | ||||||
Percentage of order of ILUVIEN units required | 80.00% | |||||||
Agreement period | 6 years | |||||||
Renewal option additional period | 1 year | 1 year | ||||||
Contract extension terms | 5 years | |||||||
Prior written notice period | 12 months | |||||||
Number of executives in employment agreements | Employee | 4 | |||||||
CRO Agreement, physician utilization study | ||||||||
Commitments and Contingencies [Line Items] | ||||||||
Clinical and data management services expense | $ 141 | 101 | ||||||
Outsourced services payable | 4 | 67 | ||||||
Clinical and data management services expense expected to be incurred | $ 210 | |||||||
ILUVIEN | ||||||||
Commitments and Contingencies [Line Items] | ||||||||
Post-authorization open study period | 5 years | |||||||
ILUVIEN | CRO Agreement, physician utilization study | ||||||||
Commitments and Contingencies [Line Items] | ||||||||
Number of contract research organizations engaged | contract | 3 | |||||||
Post-authorization open study period | 5 years | |||||||
Number of agreements for clinical and data management services | agreement | 12 | |||||||
Capital leased assets | ||||||||
Commitments and Contingencies [Line Items] | ||||||||
Depreciation expense | $ 281 | $ 172 | ||||||
Subsequent event | ||||||||
Commitments and Contingencies [Line Items] | ||||||||
Number of executives in employment agreements | Employee | 4 | |||||||
Subsequent event | Minimum | ||||||||
Commitments and Contingencies [Line Items] | ||||||||
Executives salaries | $ 332 | |||||||
Subsequent event | Maximum | ||||||||
Commitments and Contingencies [Line Items] | ||||||||
Executives salaries | $ 525 | |||||||
2018 Loan Agreement | Solar Capital Ltd. | ||||||||
Commitments and Contingencies [Line Items] | ||||||||
Feed that will be due upon repayment of the term loan | $ 1,800 |
Commitments and Contingencies_2
Commitments and Contingencies - Schedule of Future Minimum Principal Payments Under Note Payable (Detail) $ in Thousands | Dec. 31, 2018USD ($) |
Long-term Debt, Fiscal Year Maturity [Abstract] | |
2,019 | $ 0 |
2,020 | 8,333 |
2,021 | 20,000 |
2,022 | 11,667 |
Total | 40,000 |
Less unamortized repayment fee | (1,296) |
Less unamortized deferred financing costs | (831) |
Less current portion | 0 |
Non-current portion | $ 37,873 |
Commitments and Contingencies_3
Commitments and Contingencies - Schedule of Operating Lease Assets (Details) $ in Thousands | Dec. 31, 2018USD ($) |
Operating Leases, Future Minimum Payments Due, Fiscal Year Maturity [Abstract] | |
2,019 | $ 564 |
2,020 | 421 |
2,021 | 300 |
Total | $ 1,285 |
Commitments and Contingencies_4
Commitments and Contingencies - Schedule by Year of Future Minimum Payments under Capital Leases, Together with Present Value of Minimum Lease Payments (Detail) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Capital Leases, Future Minimum Payments Due, Fiscal Year Maturity [Abstract] | ||
2,019 | $ 328 | |
2,020 | 297 | |
2,021 | 76 | |
Total | 701 | |
Less amount representing interest | (42) | |
Less amount representing executory costs | (118) | |
Present value of minimum lease payments | 541 | |
Less current portion | (236) | $ (184) |
Non-current portion | $ 305 | $ 203 |
Commitments and Contingencies_5
Commitments and Contingencies - Property and Equipment Under Capital Leases (Detail) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Capital Leased Assets [Line Items] | ||
Less accumulated depreciation | $ (315) | $ (311) |
Total | 615 | 415 |
Automobiles | ||
Capital Leased Assets [Line Items] | ||
Gross capital leased assets | 870 | 663 |
Office equipment | ||
Capital Leased Assets [Line Items] | ||
Gross capital leased assets | $ 60 | $ 63 |
Preferred Stock - Series A Conv
Preferred Stock - Series A Convertible Preferred Stock (Details) - USD ($) | Oct. 02, 2012 | Dec. 31, 2017 | Dec. 31, 2014 | Dec. 31, 2018 |
Conversion of Stock [Line Items] | ||||
Gain on change in fair value of derivatives | $ 188,000 | |||
Series A convertible preferred stock | ||||
Conversion of Stock [Line Items] | ||||
Number of preferred stock and warrants (in shares) | 1,000,000 | |||
Warrants to purchase additional shares (in shares) | 300,000 | |||
Gross proceeds under securities purchase agreement | $ 40,000,000 | |||
Estimated total stock issuance cost | $ 560,000 | |||
Gross proceeds under securities purchase agreement per value (USD per share) | $ 40 | |||
Initial conversion price subjected to adjustment two (in dollars per share) | 2.66 | |||
Preferred stock converted to common stock per share (in dollars per share) | $ 10 | |||
Proceeds from issuance of preferred stock | $ 30,000,000 | |||
Proportion of each unit of shares (in shares) | 0.30 | |||
Exercise price of warrants (in dollars per share) | $ 44 | |||
Shares converted (in shares) | 400,000 | |||
Preferred stock, shares issued (in shares) | 600,000 | 600,000 | ||
Preferred stock, shares outstanding (in shares) | 600,000 | 600,000 | ||
Common Stock | ||||
Conversion of Stock [Line Items] | ||||
Shares issued in conversion of preferred stock (in shares) | 6,015,037 |
Preferred Stock - Series B Conv
Preferred Stock - Series B Convertible Preferred Stock (Details) - USD ($) | Dec. 12, 2014 | Dec. 31, 2018 | Dec. 31, 2017 |
Conversion of Stock [Line Items] | |||
Issuance of stock, net of issuance costs | $ 83,000 | $ 5,901,000 | |
Stock issuance costs incurred | $ 0 | $ 183,000 | |
Series B convertible preferred stock | |||
Conversion of Stock [Line Items] | |||
Issuance of preferred stock (in shares) | 8,291.873 | ||
Issuance of preferred stock (in dollars per share) | $ 6,030 | ||
Issuance of stock, net of issuance costs | $ 50,000,000 | ||
Stock issuance costs incurred | $ 432,000 | ||
Common stock issued upon conversion (in shares) | 1,000 | ||
Ownership interest of holders after conversion of preferred stock (percent) | 9.98% | ||
Intrinsic value of beneficial conversion feature | $ 750,000 | ||
Over-Allotment Option | Series B convertible preferred stock | |||
Conversion of Stock [Line Items] | |||
Issuance of preferred stock (in shares) | 124.378 |
Preferred Stock - Series C Conv
Preferred Stock - Series C Convertible Preferred Stock (Details) - USD ($) | Sep. 04, 2018 | Dec. 12, 2014 | Sep. 30, 2018 | Sep. 30, 2018 | Dec. 31, 2018 | Dec. 31, 2017 |
Conversion of Stock [Line Items] | ||||||
Preferred stock, par value (in dollars per share) | $ 0.01 | $ 0.01 | ||||
Payment of preferred stock exchange costs | $ 122,000 | $ 122,000 | $ 0 | |||
Issuance of preferred stock | 83,000 | 5,901,000 | ||||
Gain on extinguishment of preferred stock | $ (38,330,000) | $ (38,330,000) | (38,330,000) | 0 | ||
Stock issuance costs incurred | $ 0 | $ 183,000 | ||||
Series B convertible preferred stock | ||||||
Conversion of Stock [Line Items] | ||||||
Preferred stock, shares outstanding (in shares) | 8,416 | 8,416.251 | 8,416.251 | |||
Issuance of preferred stock (in shares) | 8,291.873 | |||||
Issuance of preferred stock | $ 50,000,000 | |||||
Common stock issued upon conversion (in shares) | 1,000 | |||||
Ownership interest of holders after conversion of preferred stock (percent) | 9.98% | |||||
Preferred stock, liquidation preference | $ 50,750,000 | $ 50,750,000 | ||||
Preferred stock | $ 0 | $ 49,568,000 | ||||
Stock issuance costs incurred | $ 432,000 | |||||
Series C Convertible Preferred Stock | ||||||
Conversion of Stock [Line Items] | ||||||
Preferred stock, shares outstanding (in shares) | 10,150 | 0 | ||||
Issuance of preferred stock (in shares) | 10,150 | |||||
Preferred stock, par value (in dollars per share) | $ 0.01 | |||||
Issuance of preferred stock | $ 10,150,000 | |||||
Conversion price per share (USD per share) | $ 1 | |||||
Common stock issued upon conversion (in shares) | 10,150,000 | |||||
Ownership interest of holders after conversion of preferred stock (percent) | 9.98% | |||||
Preferred stock, liquidation preference | $ 10,150,000 | $ 10,150,000 | $ 0 | |||
Preferred stock | $ 11,117,000 | $ 0 | ||||
Stock issuance costs incurred | 122,000 | |||||
Estimate of Fair Value Measurement | Series C Convertible Preferred Stock | ||||||
Conversion of Stock [Line Items] | ||||||
Preferred stock | $ 11,239,000 |
Stock Incentive Plans - Narrati
Stock Incentive Plans - Narrative (Detail) - USD ($) $ in Thousands | Jan. 01, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2010 |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Contractual term | 5 years 4 months 12 days | |||
Total estimated fair value of options granted | $ 2,268 | $ 2,186 | ||
Total estimated intrinsic value of options exercised (less than) | 1 | 1 | ||
Employee stock-based compensation expense | $ 3,380 | 4,060 | ||
Employee Stock Option | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Vesting period | 4 years | |||
Contractual term | 10 years | |||
Total unrecognized compensation cost related to outstanding stock option awards | $ 2,993 | |||
Total unrecognized compensation cost related to outstanding stock option awards, recognition period (in years) | 2 years 3 months 1 day | |||
Total fair value of shares vested during period | $ 3,400 | |||
Restricted stock units | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Total unrecognized compensation cost related to outstanding restricted stock units | 169 | |||
Employee stock-based compensation expense | $ 1,002 | $ 883 | ||
Directors Option Plan | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Vesting period | 4 years | |||
Contractual term | 10 years | |||
2010 Equity Incentive Plan | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Maximum number of shares the company is authorized to grant (in shares) | 263,498 | |||
Additional shares that became available for future issuance (in shares) | 2,000,000 | |||
Percentage of outstanding common stock, maximum | 4.00% | |||
2010 Equity Incentive Plan | Subsequent event | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Additional shares that became available for future issuance (in shares) | 2,000,000 |
Stock Incentive Plans - Summary
Stock Incentive Plans - Summary of Stock Option Transactions (Detail) - $ / shares | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Options | ||
Options outstanding at beginning of period (in shares) | 11,595,510 | 10,804,412 |
Grants (in shares) | 2,111,375 | 2,336,300 |
Forfeitures (in shares) | (1,257,967) | (1,544,473) |
Exercises (in shares) | (1,563) | (729) |
Options outstanding at year end (in shares) | 12,447,355 | 11,595,510 |
Options exercisable at year end (in shares) | 9,138,544 | 8,085,064 |
Weighted average per share fair value of options granted during the period (in dollars per share) | $ 0.71 | $ 0.94 |
Weighted Average Exercise Price | ||
Options outstanding at beginning of period (in dollars per share) | 2.90 | 3.22 |
Grants (in dollars per share) | 1.07 | 1.25 |
Forfeitures (in dollars per share) | 2.54 | 2.63 |
Exercises (in dollars per share) | 1.06 | 1.49 |
Options outstanding at year end (in dollars per share) | 2.63 | 2.90 |
Options exercisable at year end (in dollars per share) | $ 3.09 | $ 3.25 |
Stock Incentive Plans - Additio
Stock Incentive Plans - Additional Stock Option Transactions (Detail) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |||
Outstanding, Shares | 12,447,355 | 11,595,510 | 10,804,412 |
Exercisable, Shares | 9,138,544 | 8,085,064 | |
Outstanding, vested and expected to vest, Shares | 12,044,311 | ||
Outstanding, weighted average exercise price (in dollars per share) | $ 2.63 | $ 2.90 | $ 3.22 |
Exercisable, weighted average exercise price (in dollars per share) | 3.09 | $ 3.25 | |
Outstanding, vested and expected to vest, Weighted Average Exercise Price (in dollars per share) | $ 2.67 | ||
Outstanding, weighted average contractual term | 6 years 3 months 1 day | ||
Exercisable, weighted average contractual term | 5 years 4 months 12 days | ||
Outstanding, vested and expected to vest, Weighted Average Contractual Term | 6 years 1 month 28 days | ||
Outstanding, aggregate intrinsic value | $ 0 | ||
Exercisable, aggregate intrinsic value | 0 | ||
Outstanding, vested and expected to vest, Aggregate Intrinsic Value | $ 0 |
Stock Incentive Plans - Weighte
Stock Incentive Plans - Weighted-Average Assumptions Used for Option Grants (Detail) - $ / shares | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | ||
Risk-free interest rate (percent) | 2.63% | 2.06% |
Volatility factor (percent) | 72.60% | 90.49% |
Grant date fair value of common stock options (in dollars per share) | $ 0.71 | $ 0.94 |
Weighted-average expected life | 6 years 8 days | 6 years 8 days |
Assumed forfeiture rate (percent) | 10.00% | 10.00% |
Stock Incentive Plans - Employe
Stock Incentive Plans - Employee Stock-Based Compensation Expense (Detail) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||
Total employee stock-based compensation expense related to stock options | $ 3,380 | $ 4,060 |
Sales and marketing | ||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||
Total employee stock-based compensation expense related to stock options | 685 | 907 |
Research, development and medical affairs | ||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||
Total employee stock-based compensation expense related to stock options | 565 | 643 |
General and administrative | ||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||
Total employee stock-based compensation expense related to stock options | $ 2,130 | $ 2,510 |
Stock Incentive Plans - Summa_2
Stock Incentive Plans - Summary of Restricted Stock Unit Transactions (Details) - Restricted stock units - $ / shares | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Nonvested, Number of Shares [Roll Forward] | ||
Restricted stock units outstanding at beginning of period (in shares) | 839,285 | 0 |
Grants (in shares) | 1,091,712 | 964,720 |
Vested units (in shares) | (839,285) | 0 |
Forfeitures (in shares) | (191,460) | (125,435) |
Restricted stock units outstanding at year end (in shares) | 900,252 | 839,285 |
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Nonvested, Weighted Average Grant Date Fair Value [Abstract] | ||
Restricted stock units outstanding at beginning of period (in dollars per share) | $ 1.21 | $ 0 |
Grants (in dollars per share) | 1.15 | 1.21 |
Vested units (in dollars per share) | 1.21 | 0 |
Forfeitures (in dollars per share) | 1.15 | 1.18 |
Restricted stock units outstanding at year end (in dollars per share) | $ 1.15 | $ 1.21 |
Common Stock Warrants (Detail)
Common Stock Warrants (Detail) - $ / shares | 12 Months Ended | ||||
Dec. 31, 2018 | Dec. 31, 2017 | Oct. 31, 2016 | Jul. 31, 2016 | Apr. 30, 2014 | |
Class of Warrant or Right [Line Items] | |||||
Warrants to purchase common stock issued and outstanding (in shares) | 1,795,663 | 1,795,663 | |||
Minimum | |||||
Class of Warrant or Right [Line Items] | |||||
Warrants to purchase common, exercise prices (in dollars per share) | $ 1.09 | ||||
Warrants, exercisable period from issuance date | 5 years | ||||
Maximum | |||||
Class of Warrant or Right [Line Items] | |||||
Warrants to purchase common, exercise prices (in dollars per share) | $ 11 | ||||
Warrants, exercisable period from issuance date | 10 years | ||||
2014 Term Loan | Hercules | Alimera Sciences, Inc. | |||||
Class of Warrant or Right [Line Items] | |||||
Warrants to purchase Company's common stock, granted during period (in shares) | 285,016 | ||||
Exercise price on warrants (in dollars per share) | $ 6.14 | ||||
July 2016 Waiver | Hercules | Alimera Sciences, Inc. | |||||
Class of Warrant or Right [Line Items] | |||||
Warrants to purchase Company's common stock, granted during period (in shares) | 1,258,993 | ||||
Exercise price on warrants (in dollars per share) | $ 1.39 | ||||
Fourth Loan Amendment | Hercules | Alimera Sciences Limited | |||||
Class of Warrant or Right [Line Items] | |||||
Warrants to purchase Company's common stock, granted during period (in shares) | 458,716 | ||||
Exercise price on warrants (in dollars per share) | $ 1.09 |
Concentrations and Credit Risk
Concentrations and Credit Risk (Details) | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Revenue | Customer concentration risk | ||
Concentration Risk [Line Items] | ||
Concentration risk percentage | 69.00% | 73.00% |
Accounts receivable | Customer concentration risk | ||
Concentration Risk [Line Items] | ||
Concentration risk percentage | 73.00% | 81.00% |
Purchases | Supplier concentration risk | ||
Concentration Risk [Line Items] | ||
Concentration risk percentage | 13.70% | 10.50% |
Income Taxes - Narrative (Detai
Income Taxes - Narrative (Detail) - USD ($) | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Operating Loss Carryforwards [Line Items] | |||
Tax Cuts and Jobs Act of 2017, income tax expense | $ 0 | ||
State tax. net of federal benefit | 1,000 | $ (3,783,000) | |
Unrecognized tax benefits | 68,000 | 52,000 | $ 59,000 |
Operating loss carryforwards, not utilized in the future | 18,600,000 | ||
Federal tax credits, not utilized in the future | 382,000 | ||
Cumulative book losses in foreign subsidiaries | (126,648,000) | ||
Federal | |||
Operating Loss Carryforwards [Line Items] | |||
Net operating loss carry-forwards | 122,455,000 | 121,413,000 | |
State | |||
Operating Loss Carryforwards [Line Items] | |||
Net operating loss carry-forwards | $ 153,333,000 | $ 161,753,000 |
Income Taxes - Components of Ne
Income Taxes - Components of Net Loss before Taxes (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Income Tax Disclosure [Abstract] | ||
United States | $ (2,908) | $ (1,890) |
Foreign | (13,368) | (19,948) |
Loss before provision for income taxes | $ (16,276) | $ (21,838) |
Income Taxes - Components of In
Income Taxes - Components of Income Tax Benefit (Detail) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Current Income Tax Expense (Benefit), Continuing Operations [Abstract] | ||
Federal | $ 0 | $ 0 |
State | 0 | 0 |
Foreign | 759 | 255 |
Current income tax expense | 759 | 255 |
Deferred benefit (expense): | ||
Federal | 256 | 549 |
State | 411 | 3,330 |
Foreign | (654) | (92) |
Deferred benefit (expense), gross | 13 | 3,787 |
Valuation allowance | (666) | (3,879) |
Deferred income tax benefit | (653) | (92) |
Total income tax expense | $ 106 | $ 163 |
Income Taxes - Valuation Allowa
Income Taxes - Valuation Allowance Rollforward (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
SEC Schedule, 12-09, Valuation and Qualifying Accounts Disclosure [Line Items] | ||
Beginning balance | $ (41,485,000) | |
Ending balance | (42,151,000) | $ (41,485,000) |
Deferred Tax Asset Valuation Allowance | ||
SEC Schedule, 12-09, Valuation and Qualifying Accounts Disclosure [Line Items] | ||
Beginning balance | (41,485,000) | (55,968,000) |
Income tax provision | (666,000) | (3,879,000) |
U.S. Tax Reform | 0 | 18,362,000 |
Ending balance | $ (42,151,000) | $ (41,485,000) |
Income Taxes - Net Deferred Tax
Income Taxes - Net Deferred Tax Assets (Liabilities) (Detail) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Deferred tax assets | ||
Depreciation and amortization | $ 55 | $ 44 |
Other deferred tax assets | 1,382 | 707 |
NOL carry-forwards | 34,217 | 33,980 |
Research and development costs | 813 | 1,340 |
Equity compensation | 4,485 | 3,686 |
Collaboration agreement receivable reserves | 2,381 | 2,256 |
Valuation allowance | (42,151) | (41,485) |
Total deferred tax assets | $ 1,182 | $ 528 |
Income Taxes - Reconciliation o
Income Taxes - Reconciliation of Income Tax Benefit to Amount Determined by Applying U.S. Federal Statutory Income Tax Rate (Detail) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Amount | ||
Federal tax benefit at statutory rate | $ (3,463) | $ (7,425) |
State tax — net of federal benefit | (1) | 3,783 |
Permanent items and other | 528 | 686 |
Foreign rate differential | 2,946 | 6,880 |
U.S. tax reform | 0 | 18,362 |
Deferred rate change | (438) | (212) |
Other | (134) | 138 |
Change in valuation allowance | 666 | (14,483) |
Total income tax expense | $ 106 | $ 163 |
Percent | ||
Federal tax benefit at statutory rate | 21.00% | 34.00% |
State tax — net of federal benefit | 0.00% | 17.30% |
Permanent items and other | (3.20%) | (3.10%) |
Foreign rate differential | (17.90%) | (31.50%) |
U.S. tax reform | 0.00% | (84.10%) |
Deferred rate change | 2.70% | 1.00% |
Other | 0.80% | (0.60%) |
Change in valuation allowance | (4.00%) | 66.30% |
Total tax expense (benefit) | (0.60%) | (0.70%) |
Income Taxes - Uncertain Tax Po
Income Taxes - Uncertain Tax Positions Rollforward (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Reconciliation of Unrecognized Tax Benefits, Excluding Amounts Pertaining to Examined Tax Returns [Roll Forward] | ||
Balance of uncertain tax positions at beginning of period | $ 52 | $ 59 |
Gross increases - tax positions in current period | 13 | 4 |
Gross increases - tax positions in prior period | 10 | 0 |
Gross decreases - tax positions in prior period | (7) | (11) |
Settlements | 0 | 0 |
Lapse of statute of limitations | 0 | 0 |
Balance of uncertain tax positions at end of period | $ 68 | $ 52 |
Employee Benefit Plans (Detail)
Employee Benefit Plans (Detail) | Jan. 01, 2019shares | Jan. 01, 2018shares | Apr. 30, 2010USD ($)periodshares | Dec. 31, 2018USD ($)shares | Dec. 31, 2017USD ($)shares | Dec. 31, 2010shares |
Defined Benefit Plan Disclosure [Line Items] | ||||||
Compensation expense associated with the Company's matching plan | $ | $ 274,000 | $ 187,000 | ||||
Annual discretionary profit-sharing contribution | $ | 0 | 0 | ||||
Compensation expense recorded in connection with the Purchase Plan | $ | $ 4,411,000 | $ 4,981,000 | ||||
Employee stock purchase plan | ||||||
Defined Benefit Plan Disclosure [Line Items] | ||||||
Purchase price of stock under ESPP as a percentage of fair market value of common stock | 85.00% | 85.00% | ||||
Employee stock purchase plan, number of purchase periods | period | 2 | |||||
Employee stock purchase plan, purchase period | 6 months | |||||
Percentage of eligible compensation that may be contributed towards ESPP | 15.00% | |||||
Maximum number of shares of common stock a participant may purchase per purchase period (in shares) | shares | 2,500 | |||||
Maximum value of shares of common stock a participant may purchase in any calendar year | $ | $ 25,000 | |||||
Common stock, available for sale under employee stock purchase plan (in shares) | shares | 494,422 | |||||
Common shares acquired through employee stock purchase plan | shares | 91,649 | 79,733 | ||||
Additional shares that became available for future issuance under the Purchase Plan (in shares) | shares | 79,733 | |||||
Compensation expense recorded in connection with the Purchase Plan | $ | $ 31,000 | $ 38,000 | ||||
Employee stock purchase plan | Subsequent event | ||||||
Defined Benefit Plan Disclosure [Line Items] | ||||||
Additional shares that became available for future issuance under the Purchase Plan (in shares) | shares | 91,649 |
Segment Information - Narrative
Segment Information - Narrative (Details) - Customer concentration risk | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Revenue | ||
Segment Reporting Information [Line Items] | ||
Concentration risk percentage | 69.00% | 73.00% |
Accounts receivable | ||
Segment Reporting Information [Line Items] | ||
Concentration risk percentage | 73.00% | 81.00% |
- Segment Information (Details)
- Segment Information (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Segment Reporting Information [Line Items] | ||
NET REVENUE | $ 46,970 | $ 35,912 |
COST OF GOODS SOLD, EXCLUDING DEPRECIATION AND AMORTIZATION | (4,679) | (3,438) |
GROSS PROFIT | 42,291 | 32,474 |
RESEARCH, DEVELOPMENT AND MEDICAL AFFAIRS EXPENSES | 11,274 | 12,844 |
GENERAL AND ADMINISTRATIVE EXPENSES | 14,525 | 13,039 |
SALES AND MARKETING EXPENSES | 23,517 | 23,210 |
DEPRECIATION AND AMORTIZATION | 2,645 | 2,684 |
RECOVERABLE COLLABORATION COSTS | 0 | (2,851) |
OPERATING EXPENSES | 51,961 | 48,926 |
NET LOSS FROM OPERATIONS | (9,670) | (16,452) |
OTHER INCOME AND EXPENSES, NET | (6,606) | (5,386) |
NET LOSS BEFORE TAXES | (16,276) | (21,838) |
U.S. | ||
Segment Reporting Information [Line Items] | ||
NET REVENUE | 32,337 | 26,146 |
COST OF GOODS SOLD, EXCLUDING DEPRECIATION AND AMORTIZATION | (3,246) | (2,482) |
GROSS PROFIT | 29,091 | 23,664 |
RESEARCH, DEVELOPMENT AND MEDICAL AFFAIRS EXPENSES | 6,457 | 5,780 |
GENERAL AND ADMINISTRATIVE EXPENSES | 8,147 | 7,580 |
SALES AND MARKETING EXPENSES | 16,569 | 16,588 |
DEPRECIATION AND AMORTIZATION | 0 | 0 |
RECOVERABLE COLLABORATION COSTS | 0 | |
OPERATING EXPENSES | 31,173 | 29,948 |
NET LOSS FROM OPERATIONS | (2,082) | (6,284) |
International | ||
Segment Reporting Information [Line Items] | ||
NET REVENUE | 14,633 | 9,766 |
COST OF GOODS SOLD, EXCLUDING DEPRECIATION AND AMORTIZATION | (1,433) | (956) |
GROSS PROFIT | 13,200 | 8,810 |
RESEARCH, DEVELOPMENT AND MEDICAL AFFAIRS EXPENSES | 3,946 | 3,314 |
GENERAL AND ADMINISTRATIVE EXPENSES | 3,259 | 2,605 |
SALES AND MARKETING EXPENSES | 5,910 | 5,394 |
DEPRECIATION AND AMORTIZATION | 0 | 0 |
RECOVERABLE COLLABORATION COSTS | 0 | |
OPERATING EXPENSES | 13,115 | 11,313 |
NET LOSS FROM OPERATIONS | 85 | (2,503) |
Other Segments | ||
Segment Reporting Information [Line Items] | ||
NET REVENUE | 0 | 0 |
COST OF GOODS SOLD, EXCLUDING DEPRECIATION AND AMORTIZATION | 0 | 0 |
GROSS PROFIT | 0 | 0 |
RESEARCH, DEVELOPMENT AND MEDICAL AFFAIRS EXPENSES | 871 | 3,750 |
GENERAL AND ADMINISTRATIVE EXPENSES | 3,119 | 2,854 |
SALES AND MARKETING EXPENSES | 1,038 | 1,228 |
DEPRECIATION AND AMORTIZATION | 2,645 | 2,684 |
RECOVERABLE COLLABORATION COSTS | (2,851) | |
OPERATING EXPENSES | 7,673 | 7,665 |
NET LOSS FROM OPERATIONS | (7,673) | (7,665) |
OTHER INCOME AND EXPENSES, NET | $ (6,606) | $ (5,386) |